Rigor Reviewed

Rigor-Reviewed Manuscript

Colchicine in Acute Myocardial Infarction.

Name: Αlpha¹ Rigor Record — Colchicine in Acute Myocardial Infarction.
Item: Colchicine in Acute Myocardial Infarction.
Rating: 39
Author: Αlpha¹

Jolly SS, d'Entremont MA, 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, Layland J, Zafirovska B, Devereaux PJ, Eikelboom J, Cairns JA, Shah B, Sheth T, Sharma SK, Tarhuni W, Conen D, Tawadros S, Lavi S, Yusuf S, CLEAR Investigators

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Αlpha¹ Rigor Review — 1★ (Critical), 2 critical, 2 high issues for “Colchicine in Acute Myocardial Infarction.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 16, 2026

Αlpha¹ Rigor Review

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★
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: 6 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.

Problems surfaced4 types

Numerical inconsistencies2

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
Internal contradictions in the reported numbersAssessed

Overstated conclusions1

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.

Conclusions only partially backed by the presented evidenceAssessed

Reporting gaps1

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

This Αlpha¹ Rigor Review uses AI 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.

Critical findings

• PERCENT: 2.7% does not match the reported count 137/3528
• PERCENT: 2.8% does not match the reported count 139/3534

This is a well-conducted and well-reported randomized clinical trial with rigorous design, clear ethics approvals, and appropriate statistical methods. The main weaknesses are the absence of a data availability statement, lack of explicit statistical software identification, and minor copyedit issues including a potential denominator inconsistency.

This is an interventional clinical trial; all dimensions were applicable except those specific to animal or cell-line research. The two reviewers agreed on all dimensions; no divergence to reconcile. The statistics verification covered only a subset of tests (5 recomputed, 3 consistent, 2 inconsistent but no decision errors), so the statistical analysis is not fully verified.

8 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Recomputed 3 tests: 3 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 2 via agent-written checks. 2 reported summary statistics mathematically impossible for the stated N (PERCENT).

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites multiple prior trials (COLCOT, LoDoCo2, CHANCE, CONVINCE) and notes both beneficial and null results, acknowledging the need for more data. The rationale for the trial is clearly stated: 'Given the biological rationale and encouraging evidence, we conducted the CLEAR trial to provide examine the effect of colchicine in post-myocardial infarction patients.' Limitations of prior work are implicitly addressed by designing a larger trial with more events, as discussed in the Discussion.

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 by citing prior trials and biological rationale for colchicine, and logically links this to the study objective.

Evidence

direct quote[Introduction, paragraph 1]

“A trial of 4745 patients where colchicine was initiated within 30 days of a myocardial infarction and a trial of 5522 patients with stable coronary artery disease reported beneficial cardiovascular effects of colchicine, whereas 2 recent trials in patients with ischemic stroke (n=8343, n=3154) reported no reductions in cardiovascular events with colchicine with the caveat that one trial was a short term treatment trial (3 months).”