Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Routine Spironolactone in Acute Myocardial Infarction.

Name: Kaimen Rigor review — Routine Spironolactone in Acute Myocardial Infarction.
Item: Routine Spironolactone in Acute Myocardial Infarction.
Rating: 39
Author: Alpha1

Jolly SS, d'Entremont MA, Pitt B, Lee SF, Mian R, Tyrwhitt J, Kedev S, Montalescot G, Cornel JH, Stanković G, Moreno R, Storey RF, Henry TD, Mehta SR, Bossard M, Kala P, Bhindi R, Zafirovska B, Devereaux PJ, Eikelboom J, Cairns JA, Natarajan MK, Schwalm JD, Sharma SK, Tarhuni W, Conen D, Tawadros S, Lavi S, Asani V, Topic D, Cantor WJ, Bertrand OF, Pourdjabbar A, Yusuf S, CLEAR investigators, CLEAR Investigators

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Kaimen Rigor review — 1★ (Critical), 2 critical, 2 high issues for “Routine Spironolactone in Acute Myocardial Infarction.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Routine Spironolactone in Acute Myocardial Infarction.

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DOI

10.1056/NEJMoa2405923

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5f402a66bb6832159f309c50186bb6637cc0efb716f53d1204eb97d31fd48ee3

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Issued Aug 16, 2026Engine 7.39.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Routine Spironolactone in Acute Myocardial Infarction.

Paper source

Routine Spironolactone in Acute Myocardial Infarction.

Read full text

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic ×2−2★
IntegrityIntegrity concern−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
ReportingData & code availability partially met−0.25★

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Biggest issues2 demonstrable

01Printed percentage does not match its own countdemonstrable
criticalArithmeticrecomputedFull detail
1.7% does not match the reported count 183/3537
“183 (1.7)”
Table 2
02Printed percentage does not match its own countdemonstrable
criticalArithmeticrecomputedFull detail
2.1% does not match the reported count 220/3525
“220 (2.1)”
Table 2
03Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The trial reports no statistically significant benefit on either co-primary outcome. The hazard ratios are close to 1 (0.91 and 0.95) with confidence intervals crossing 1, and the authors acknowledge that a clinically important benefit cannot be excluded. The effect sizes are not anchored to a minimal clinically important difference, and the conclusion is that spironolactone did not reduce outcomes.
“Post myocardial infarction, spironolactone, did not reduce either co-primary outcomes.”
Find in source
04Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
66.4% does not match the reported count 2349/3525
“2349 (66.4)”
Table 1
05Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
0.2% does not match the reported count 11/3537
“11 (0.2)”
Table 1

Findings by category

301ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit4 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted randomized controlled trial with rigorous design, clear reporting of ethics, and appropriate statistical methods. The main weaknesses are the lack of an explicit data availability statement and the failure to name the statistical software, both of which are minor reporting gaps. The copyedit issues are minor and do not affect the scientific integrity.

Both reviewers agreed on all dimensions; no divergence to reconcile. The statistics verification component checked only a subset of reported tests (those with test statistics + df or effect estimates + CI); 4 of 8 recomputed consistently, but the 4 inconsistent tests are not listed and no decision errors were found, so this does not constitute a demonstrable error. The citation check found no retracted or unresolvable references. The integrity check noted a low-severity internal consistency observation that is not a contradiction.

Numerical inconsistencies

3 findings · worst critical

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 2 via agent-written checks. 2 reported summary statistics mathematically impossible for the stated N (PERCENT). 2 printed percentages that do not match their own count.

Overstated conclusions

2 findings · worst high

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

3 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites prior trials (RALES, EPHESUS, ALBATROSS) and explains the uncertainty about routine spironolactone use post-MI. The rationale is logical: aldosterone antagonism reduces mortality in heart failure, but benefit in all post-MI patients is uncertain. Limitations of prior research (e.g., ALBATROSS not powered for mortality) are acknowledged, and the need for a large trial is identified.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

“Aldosterone antagonism with spironolactone has been shown to reduce mortality in patients with chronic heart failure with reduced ejection fraction, and is a cornerstone of therapy.”

Introduction ¶1Find in source

“We conducted the CLEAR trial to evaluate if routine spironolactone use is beneficial in patients post myocardial infarction.”

Introduction ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior trials and identifying the uncertainty regarding routine spironolactone use post-MI.

Evidence

paraphrase[Introduction, paragraph 1]

“A trial of routine aldosterone antagonism with spironolactone in addition to standard therapy in 1603 post-myocardial infarction patients without heart failure showed no improvement in outcomes. However, there was a significant reduction of mortality in the ST-elevation myocardial infarction subgroup (n=1229), identifying the need for a large trial.”

“We conducted the CLEAR trial to evaluate if routine spironolactone use is beneficial in patients post myocardial infarction.”

IntroductionFind in source

Randomization used permuted blocks within a 24-hour computerized central system, stratified by center and MI type. All participants, investigators, healthcare providers, data collectors, and outcome adjudicators were blinded. A priori sample size calculations were provided and updated based on blinded event rates. Inclusion/exclusion criteria were pre-specified and modified with a protocol amendment. The intention-to-treat principle was pre-specified. Outlier handling is not explicitly described, but missing data were rare and handled appropriately. Controls are inherent in the placebo group. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified analyses.

Evidence

“Randomization was performed using permuted blocks within a 24-hour computerized central system at the Population Health Research Institute.”

MethodsFind in source

“All participants, investigators, healthcare providers, data collectors and outcome adjudicators were blinded to treatment allocation.”

MethodsFind in source

“Based on the above assumptions, it was estimated that 4,000 participants (an expected 512 events) were needed to detect a 25% relative risk reduction using a log-rank test.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified analyses.

Evidence

“Randomization was performed using permuted blocks within a 24-hour computerized central system at the Population Health Research Institute. Randomization was stratified by study center and whether the patient had a STEMI or NSTEMI.”

MethodsFind in source

“All participants, investigators, healthcare providers, data collectors and outcome adjudicators were blinded to treatment allocation.”

MethodsFind in source

“Based on the above assumptions, it was estimated that 4,000 participants (an expected 512 events) were needed to detect a 25% relative risk reduction using a log-rank test.”

MethodsFind in source

The paper reports age (mean 61 years), sex (20.4% female), and various comorbidities (diabetes, hypertension, prior MI). Demographics are detailed in Table 1. Since both sexes are enrolled, sex_justified is not applicable. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, and comorbidities.

Evidence

“Baseline characteristics were well balanced between the groups, with mean age was 61 years and 20.4% of patients were female (Table 1).”

Results ¶1Find in source

“Approximately 9% had prior myocardial infarction, 0.8% had a history of heart failure, and 19% had diabetes mellitus.”

Results ¶1Find in source

PASSReviewer 2· 90% conf

Key demographic and clinical characteristics are reported, including age, sex, and comorbidities.

Evidence

“Baseline characteristics were well balanced between the groups, with mean age was 61 years and 20.4% of patients were female (Table 1).”

Results ¶1Find in source

“Approximately 9% had prior myocardial infarction, 0.8% had a history of heart failure, and 19% had diabetes mellitus.”

Results ¶1Find in source

The paper states that ethics committees of participating centers and national regulatory authorities approved the trial, and all patients provided written informed consent. This satisfies both irb_ethics_statement and informed_consent. Regulatory compliance is implied by the approval statement.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval and informed consent are clearly documented.

Evidence

“Ethics committees of participating centers and national regulatory authorities approved the trial.”

Methods ¶2Find in source

“All patients provided written informed consent.”

Methods ¶2Find in source

PASSReviewer 2· 95% conf

Ethics approval and informed consent are clearly documented.

Evidence

“Ethics committees of participating centers and national regulatory authorities approved the trial.”

Methods ¶2Find in source

“All patients provided written informed consent.”

Methods ¶2Find in source

The study drug spironolactone is identified with manufacturer (Tiofarma, The Netherlands) and dose (25 mg). The statistical software is not explicitly named, but the analysis methods are described. Since this is a drug trial, bench resources like antibodies and cell lines are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (spironolactone) is adequately identified, and statistical software is identified.

Evidence

“Study drugs were spironolactone tablets of 25 mg and colchicine tablets of 0.5 mg with matching placebos for each.”

MethodsFind in source

absence[Methods, Statistical Considerations]

Statistical software is not explicitly named.

PASSReviewer 2· 90% conf

The investigational product (spironolactone) is adequately identified, and statistical software is identified.

Evidence

“Study drugs were spironolactone tablets of 25 mg and colchicine tablets of 0.5 mg with matching placebos for each. Tiofarma, The Netherlands, provided both study drugs with raw materials produced by Indena S.p.A., Milan, Italy.”

MethodsFind in source

absence[Methods, Statistical Considerations]

Statistical software is not explicitly named.

The paper names the statistical tests used (log-rank, Cox proportional hazards, Prentice-Williams-Peterson model, Fine-Gray). Assumptions are handled by design (e.g., stratified Cox model). Exact p-values are reported for primary outcomes. Effect sizes with 95% CIs are reported throughout. Statistical software is not explicitly identified, but this is a minor omission. Data presentation includes Kaplan-Meier curves and per-group n. Mathematical plausibility checks were not performed due to lack of raw data.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedINADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with effect sizes and confidence intervals reported.

Evidence

“Co-primary 2 (cardiovascular death, myocardial infarction, stroke or new or worsening heart failure) was analyzed as a time-to-first-event using the log-rank test for the P-value and a stratified (by allocation to colchicine and MI type) and Cox proportional hazards model for the effect size and 95% confidence intervals.”

MethodsFind in source

“competing risk hazard ratio 0.91; 95% confidence interval (CI) 0.69-1.21, p=0.51”

AbstractFind in source

“Co-primary outcome 2 occurred in 280 of 3537 patients (7.9%) in the spironolactone group compared with 294 of 3525 patients (8.3%) in the placebo group (hazard ratio [HR], 0.95; 95% CI 0.80-1.12; P=0.52”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with effect sizes and confidence intervals reported.

Evidence

MethodsFind in source

“competing risk hazard ratio 0.91; 95% confidence interval (CI) 0.69-1.21, p=0.51”

AbstractFind in source

The paper does not include an explicit data availability statement in the provided text. The trial is registered, but no repository deposit or accession numbers are mentioned. Since this is a clinical trial with patient data, repository deposit and accession numbers are not applicable. Code sharing is not applicable as no bespoke code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no code is shared.

Evidence

absence[Entire paper]

No data availability statement is found.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, and no code is shared.

Evidence

absence[Entire paper]

No data availability statement is found.

The trial is registered (NCT03048825). Methods are detailed enough for replication. Limitations are explicitly discussed, including low event rates and underrepresentation of women. Conclusions are proportional to the results. Funding and COI are stated.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov number NCT03048825”

AbstractFind in source

“First, based on the 95% CI of the primary outcome results, we cannot exclude a beneficial relative risk reduction of 27% or smaller that could be clinically important.”

LimitationsFind in source

“The study was supported by Canadian Institutes of Health, Boston Scientific and Population Health Research Institute, Hamilton, Canada.”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov number NCT03048825”

AbstractFind in source

“First, based on the 95% CI of the primary outcome results, we cannot exclude a beneficial relative risk reduction of 27% or smaller that could be clinically important.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found · partly checked

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 20 references by DOI: 18 verified — 2 no DOI (shown, not verified).

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported; an informed reader should weigh the minor reporting gaps (no data availability statement, unnamed statistical software) and the fact that only a subset of statistics were machine-verified. No erratum or correction is warranted based on the identified issues, but the authors should consider adding a data availability statement and naming the software in any future version or correction.

1.
CRITICALstatistics
Correct or explain the statistically impossible value: PERCENT: 1.7% does not match the reported count 183/3537
Demonstrable critical failure — blocks the verdict from passing.
2.
CRITICALstatistics
Correct or explain the statistically impossible value: PERCENT: 2.1% does not match the reported count 220/3525
Demonstrable critical failure — blocks the verdict from passing.
3.
HIGHdata code
Add an explicit data availability statement in the Methods or a dedicated section, specifying how de-identified patient data can be accessed (e.g., via a data access committee or a repository like Vivli).
The paper currently lacks any data availability statement, which is a transparency gap for a data-driven clinical trial.
4.
HIGHstatistics
Explicitly name the statistical software (e.g., SAS version, R version) used for analyses in the Statistical Considerations section.
The statistical software is not identified, which is a reproducibility gap.
5.
MEDIUMreporting
Mention adherence to a reporting guideline (e.g., CONSORT) in the Methods or a footnote.
The paper follows CONSORT-like structure but does not explicitly state adherence, which is a minor transparency improvement.
6.
MEDIUMreporting
Provide a link to the full trial protocol or statistical analysis plan in the supplementary materials.
This would enhance transparency and allow readers to verify pre-specified analyses.
7.
MEDIUMdata code
If feasible, deposit aggregate data or summary statistics in a public repository to enhance transparency.
This would partially address the lack of a data availability statement.
8.
MEDIUMstatistics
Clarify the handling of missing data for the 45 patients with unknown vital status in the statistical methods.
The paper mentions these patients but does not describe how they were handled in the analysis.
9.
LOWcopyedit
In the Abstract, Results, remove the extra comma and space before the period in 'only 45 (0.6%) had an unknown vital status, .'
This is a typographical error that should be corrected.
10.
LOWcopyedit
In the Results, Efficacy, ensure consistent use of 'competing risk' vs 'competing risks'.
Inconsistent terminology may confuse readers.
11.
LOWcopyedit
In the Discussion, paragraph 1, remove the stray comma and space before 'Our' in 'We did not demonstrate a reduction in mortality with spironolactone.,Our results are consistent'.
This is a punctuation error that should be fixed.
12.
LOWcopyedit
In the Results, Efficacy, ensure consistent capitalization of 'P' vs 'p' for p-values throughout.
Inconsistent capitalization of p-values is a minor style issue.

Full text (29,886 chars)Analyzed: Aug 16, 2026

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Routine Spironolactone in Acute Myocardial Infarction.

Read full text

DOI

10.1056/NEJMoa2405923

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5f402a66bb6832159f309c50186bb6637cc0efb716f53d1204eb97d31fd48ee3

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic ×2−2★
IntegrityIntegrity concern−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
ReportingData & code availability partially met−0.25★

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Biggest issues2 demonstrable

01Printed percentage does not match its own countdemonstrable
criticalArithmeticrecomputedFull detail
1.7% does not match the reported count 183/3537
“183 (1.7)”
Table 2
02Printed percentage does not match its own countdemonstrable
criticalArithmeticrecomputedFull detail
2.1% does not match the reported count 220/3525
“220 (2.1)”
Table 2
03Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The trial reports no statistically significant benefit on either co-primary outcome. The hazard ratios are close to 1 (0.91 and 0.95) with confidence intervals crossing 1, and the authors acknowledge that a clinically important benefit cannot be excluded. The effect sizes are not anchored to a minimal clinically important difference, and the conclusion is that spironolactone did not reduce outcomes.
“Post myocardial infarction, spironolactone, did not reduce either co-primary outcomes.”
Find in source
04Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
66.4% does not match the reported count 2349/3525
“2349 (66.4)”
Table 1
05Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
0.2% does not match the reported count 11/3537
“11 (0.2)”
Table 1

Findings by category

301ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit4 minor suggestions

Numerical inconsistencies

3 findings · worst critical

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Overstated conclusions

2 findings · worst high

Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

3 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

“Aldosterone antagonism with spironolactone has been shown to reduce mortality in patients with chronic heart failure with reduced ejection fraction, and is a cornerstone of therapy.”

Introduction ¶1Find in source

“We conducted the CLEAR trial to evaluate if routine spironolactone use is beneficial in patients post myocardial infarction.”

Introduction ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior trials and identifying the uncertainty regarding routine spironolactone use post-MI.

Evidence

paraphrase[Introduction, paragraph 1]

“We conducted the CLEAR trial to evaluate if routine spironolactone use is beneficial in patients post myocardial infarction.”

IntroductionFind in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified analyses.

Evidence

“Randomization was performed using permuted blocks within a 24-hour computerized central system at the Population Health Research Institute.”

MethodsFind in source

“All participants, investigators, healthcare providers, data collectors and outcome adjudicators were blinded to treatment allocation.”

MethodsFind in source

“Based on the above assumptions, it was estimated that 4,000 participants (an expected 512 events) were needed to detect a 25% relative risk reduction using a log-rank test.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified analyses.

Evidence

MethodsFind in source

“All participants, investigators, healthcare providers, data collectors and outcome adjudicators were blinded to treatment allocation.”

MethodsFind in source

“Based on the above assumptions, it was estimated that 4,000 participants (an expected 512 events) were needed to detect a 25% relative risk reduction using a log-rank test.”

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, and comorbidities.

Evidence

“Baseline characteristics were well balanced between the groups, with mean age was 61 years and 20.4% of patients were female (Table 1).”

Results ¶1Find in source

“Approximately 9% had prior myocardial infarction, 0.8% had a history of heart failure, and 19% had diabetes mellitus.”

Results ¶1Find in source

PASSReviewer 2· 90% conf

Key demographic and clinical characteristics are reported, including age, sex, and comorbidities.

Evidence

“Baseline characteristics were well balanced between the groups, with mean age was 61 years and 20.4% of patients were female (Table 1).”

Results ¶1Find in source

“Approximately 9% had prior myocardial infarction, 0.8% had a history of heart failure, and 19% had diabetes mellitus.”

Results ¶1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval and informed consent are clearly documented.

Evidence

“Ethics committees of participating centers and national regulatory authorities approved the trial.”

Methods ¶2Find in source

“All patients provided written informed consent.”

Methods ¶2Find in source

PASSReviewer 2· 95% conf

Ethics approval and informed consent are clearly documented.

Evidence

“Ethics committees of participating centers and national regulatory authorities approved the trial.”

Methods ¶2Find in source

“All patients provided written informed consent.”

Methods ¶2Find in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (spironolactone) is adequately identified, and statistical software is identified.

Evidence

“Study drugs were spironolactone tablets of 25 mg and colchicine tablets of 0.5 mg with matching placebos for each.”

MethodsFind in source

absence[Methods, Statistical Considerations]

Statistical software is not explicitly named.

PASSReviewer 2· 90% conf

The investigational product (spironolactone) is adequately identified, and statistical software is identified.

Evidence

MethodsFind in source

absence[Methods, Statistical Considerations]

Statistical software is not explicitly named.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedINADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with effect sizes and confidence intervals reported.

Evidence

MethodsFind in source

“competing risk hazard ratio 0.91; 95% confidence interval (CI) 0.69-1.21, p=0.51”

AbstractFind in source

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with effect sizes and confidence intervals reported.

Evidence

MethodsFind in source

“competing risk hazard ratio 0.91; 95% confidence interval (CI) 0.69-1.21, p=0.51”

AbstractFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no code is shared.

Evidence

absence[Entire paper]

No data availability statement is found.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, and no code is shared.

Evidence

absence[Entire paper]

No data availability statement is found.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov number NCT03048825”

AbstractFind in source

“First, based on the 95% CI of the primary outcome results, we cannot exclude a beneficial relative risk reduction of 27% or smaller that could be clinically important.”

LimitationsFind in source

“The study was supported by Canadian Institutes of Health, Boston Scientific and Population Health Research Institute, Hamilton, Canada.”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov number NCT03048825”

AbstractFind in source

“First, based on the 95% CI of the primary outcome results, we cannot exclude a beneficial relative risk reduction of 27% or smaller that could be clinically important.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found · partly checked

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 20 references by DOI: 18 verified — 2 no DOI (shown, not verified).

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
CRITICALstatistics
Correct or explain the statistically impossible value: PERCENT: 1.7% does not match the reported count 183/3537
Demonstrable critical failure — blocks the verdict from passing.
2.
CRITICALstatistics
Correct or explain the statistically impossible value: PERCENT: 2.1% does not match the reported count 220/3525
Demonstrable critical failure — blocks the verdict from passing.
3.
HIGHdata code
Add an explicit data availability statement in the Methods or a dedicated section, specifying how de-identified patient data can be accessed (e.g., via a data access committee or a repository like Vivli).
The paper currently lacks any data availability statement, which is a transparency gap for a data-driven clinical trial.
4.
HIGHstatistics
Explicitly name the statistical software (e.g., SAS version, R version) used for analyses in the Statistical Considerations section.
The statistical software is not identified, which is a reproducibility gap.
5.
MEDIUMreporting
Mention adherence to a reporting guideline (e.g., CONSORT) in the Methods or a footnote.
The paper follows CONSORT-like structure but does not explicitly state adherence, which is a minor transparency improvement.
6.
MEDIUMreporting
Provide a link to the full trial protocol or statistical analysis plan in the supplementary materials.
This would enhance transparency and allow readers to verify pre-specified analyses.
7.
MEDIUMdata code
If feasible, deposit aggregate data or summary statistics in a public repository to enhance transparency.
This would partially address the lack of a data availability statement.
8.
MEDIUMstatistics
Clarify the handling of missing data for the 45 patients with unknown vital status in the statistical methods.
The paper mentions these patients but does not describe how they were handled in the analysis.
9.
LOWcopyedit
In the Abstract, Results, remove the extra comma and space before the period in 'only 45 (0.6%) had an unknown vital status, .'
This is a typographical error that should be corrected.
10.
LOWcopyedit
In the Results, Efficacy, ensure consistent use of 'competing risk' vs 'competing risks'.
Inconsistent terminology may confuse readers.
11.
LOWcopyedit
In the Discussion, paragraph 1, remove the stray comma and space before 'Our' in 'We did not demonstrate a reduction in mortality with spironolactone.,Our results are consistent'.
This is a punctuation error that should be fixed.
12.
LOWcopyedit
In the Results, Efficacy, ensure consistent capitalization of 'P' vs 'p' for p-values throughout.
Inconsistent capitalization of p-values is a minor style issue.

Full text (29,886 chars)Analyzed: Aug 16, 2026