Rigor Reviewed

Rigor-Reviewed Manuscript

Asundexian for Secondary Stroke Prevention.

Name: Αlpha¹ Rigor Record — Asundexian for Secondary Stroke Prevention.
Item: Asundexian for Secondary Stroke Prevention.
Rating: 96
Author: Αlpha¹

Sharma M, Dong Q, Hirano T, Kasner SE, Saver JL, Masjuan J, Demchuk AM, Cordonnier C, Bereczki D, Tsivgoulis G, Veltkamp R, Staikov I, Bae HJ, Campbell BCV, Zini A, Lee IH, Kovar M, Mikulik R, Lemmens R, Ferro JM, Robinson T, Christensen H, Ozturk S, Leker RR, Turcani P, Slowik A, Amaya P, Hoo FK, De Marchis GM, Knoflach M, Sylaja PN, Putaala J, Coutinho JM, van der Worp HB, Miglane E, Matijošaitis V, Lindgren AG, Sampaio Silva G, Sandset EC, Turuspekova ST, Amarenco P, Sheth KN, Smith EE, Eikelboom JW, Joundi RA, Schulze K, Xu L, Heenan L, Colorado P, Keller L, Muehlhofer E, Neumann C, Mundl H, Shoamanesh A, OCEANIC-STROKE Investigators

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Αlpha¹ Rigor Review — 4.75★ (Strong), 0 critical, 2 high issues for “Asundexian for Secondary Stroke Prevention.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Problems surfaced1 type

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.

This is a well-conducted phase 3 randomized controlled trial with rigorous design, clear reporting of methods, and appropriate statistical analysis. The main weakness is the vague data sharing statement, which lacks specific access mechanisms. Minor reporting gaps include not naming the statistical software and not explicitly citing a reporting guideline.

Both reviewers agreed on all dimensions; no divergence. The study is an interventional trial; all non-applicable sub-criteria (e.g., animal housing, cell lines) were excluded. The statistics verification recomputed 5 reported tests consistently, but this does not confirm the entire statistical analysis.

4 major claims checked against the paper's own evidence: all adequately supported.

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

Recomputed 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites epidemiological and genetic evidence that low factor XI levels reduce ischemic stroke risk, and a phase 2 trial suggesting efficacy without increased bleeding. The rationale for the trial follows logically from this evidence. Limitations of prior work are implicitly addressed by the design of a large phase 3 trial, though not explicitly discussed as limitations.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale linking factor XI inhibition to stroke prevention.

Evidence

paraphrase[Introduction, paragraph 1]

“Genetic factor XI deficiency is associated with a reduced risk of ischemic stroke without an increase in intracerebral bleeding, and increased levels of factor XI are associated with a higher risk of ischemic stroke.”

paraphrase[Introduction, paragraph 2]

“In a phase 2 trial involving patients with noncardioembolic ischemic stroke, asundexian added to antiplatelet therapy appeared to reduce the occurrence of symptomatic ischemic stroke without a significant increase in the incidence of major or clinically relevant nonmajor bleeding.”

paraphrase[Introduction, paragraph 2]

“We designed the Oral Factor Eleven A Inhibitor Asundexian as Novel Antithrombotic Stroke (OCEANIC-STROKE) trial to evaluate the efficacy and safety of asundexian for secondary stroke prevention.”

PASSReviewer 2· 95% conf

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

Evidence

paraphrase[Introduction, paragraph 1]

paraphrase[Introduction, paragraph 2]

“The apparent dissociation of hemostasis and pathologic thrombosis makes factor XI an attractive therapeutic target for stroke prevention.”

paraphrase[Introduction, paragraph 2]

Randomization was performed via an interactive web-based system with stratification, and the trial was double-blind. A priori power analysis was reported with assumptions. Inclusion/exclusion criteria were detailed. The analysis population (ITT for efficacy, safety population for safety) was defined, addressing missing data and discontinuations. Blinding of outcome adjudication was described.

Sub-criteria

controlsN/A

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 inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and Treatments]

“Randomization was performed by means of an interactive Web-based system and was stratified according to planned antiplatelet treatment as determined by the treating physician.”

paraphrase[Methods, Trial Design and Oversight]

“We conducted this phase 3, double-blind, event-driven, randomized, placebo-controlled trial.”

direct quote[Methods, Statistical Analysis]

“The required number of patients was determined on the basis of the assumption that 6.3% of the patients in the placebo group would have had an event at 12 months, a type I error rate of 5% (two-sided), and 90% power for the trial to achieve a hazard ratio of 0.80.”