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Asundexian for Secondary Stroke Prevention
Mukul Sharma, Qiang Dong, Teruyuki Hirano, Scott Eric Kasner, Jeffrey L. Saver, Jaime Masjuan, Andrew M. Demchuk, Charlotte Cordonnier et al.. New England Journal of Medicine, 2026-04-15
Topic: Risk, prevention and care in population studies
Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001). The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group. The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44). The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively. Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding. (Funded by Bayer; OCEANIC-STROKE ClinicalTrials.gov number, NCT05686070.).
Key findings
- Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001).
- The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group.
- The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44).
- The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively.
- Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding.
Why it matters
In this large trial of people who had a noncardioembolic ischemic stroke or high-risk TIA and were already taking antiplatelet therapy, adding asundexian at 50 mg daily lowered the risk of ischemic stroke and of major cardiovascular events compared with placebo. Major bleeding rates were similar between the two groups, so this treatment may help prevent further strokes without a higher bleeding risk.
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Study details
- Study designclinical trial
- Participants12,327
- Effect size6.2%; 8.4%; 1.9%
- Evidence strengthLow
How this study scored 68/100
Published in a top-tier journal. Scored zero for study design and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 10 / 10 | Tier 1 — top-tier general journal (New England Journal of Medicine) |
| Journal's citation record | 4 / 4 | New England Journal of Medicine: journal h-index 1,505 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 4 / 4 | 12,327 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 4 / 7 | Cited 41 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 20.5 citations a year over 2 year(s) since 2026 |
| Impact for its field and year | 6 / 6 | Cited 183.3× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 1 other studies in this library |
| Still being cited | 2 / 4 | Cited 41 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Ashkan Shoamanesh: h-index 54 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Inserm: institution h-index 1,988 (OpenAlex) |
| Multi-centre collaboration | 3 / 3 | OpenAlex lists 67 institution(s) in 36 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41985132) |
| Free to read | 2 / 2 | Free to read |
| Total | 68 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Sharma, M., Dong, Q., Hirano, T., Kasner, S. E., Saver, J. L., Masjuan, J., et al. (2026). Asundexian for Secondary Stroke Prevention. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2513880
Vancouver
Sharma M, Dong Q, Hirano T, Kasner SE, Saver JL, Masjuan J, et al. Asundexian for Secondary Stroke Prevention. New England Journal of Medicine. 2026. doi:10.1056/nejmoa2513880. PMID: 41985132.
BibTeX
@article{sharma2026-41985132,
author = {Sharma, Mukul and Dong, Qiang and Hirano, Teruyuki and Kasner, Scott Eric and Saver, Jeffrey L. and Masjuan, Jaime and Demchuk, Andrew M. and Cordonnier, Charlotte and others},
title = {{Asundexian for Secondary Stroke Prevention}},
journal = {New England Journal of Medicine},
year = {2026},
doi = {10.1056/nejmoa2513880},
pmid = {41985132},
url = {https://doi.org/10.1056/nejmoa2513880}
}
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