Newly Published Phase 3 OCEANIC-STROKE Trial Data Show Asundexian Reduces Recurrent Ischemic Stroke Risk

Newly published in the New England Journal of Medicine, results from the global, pivotal phase 3 OCEANIC-STROKE trial (NCT05686070) evaluating asundexian (Bayer), an investigational factor XIa inhibitor, showed that a 50-mg daily dose was associated with lower risks of ischemic stroke compared with placebo among patients treated with antiplatelet therapy after a noncardioembolic ischemic stroke or high-risk transient ischemic attack, without an increased risk of major bleeding.^1,2

“Non-cardioembolic ischemic strokes account for approximately 45% of the 12 million strokes occurring globally each year. Despite guideline-recommended therapy, these patients remain at substantial risk of recurrence, with approximately 1 in 10 experiencing another stroke within one year,” Ashkan Shoamanesh, MD, co‑principal investigator of OCEANIC-STROKE study and PHRI senior scientist, told NeurologyLive^®. “These findings support the potential of asundexian as a broadly applicable therapeutic option for patients with non-cardioembolic ischemic stroke or high-risk TIA who meet trial eligibility criteria.”

Among 12,327 randomized patients (asundexian, n = 6162; placebo, n = 6165), the incidence of ischemic stroke, the primary efficacy outcome, was lower in the asundexian group compared with the placebo group (6.2% vs 8.4%; cause-specific hazard ratio, 0.74; 95% CI, 0.65–0.84; P <.001). In terms of secondary efficacy outcomes, findings showed that ischemic or hemorrhagic stroke occurred in 404 patients (6.6%) in the asundexian group compared with 545 patients (8.8%) in the placebo group (cause-specific hazard ratio, 0.74; 95% CI, 0.65 to 0.84; P <.001).

“The publication of OCEANIC-STROKE builds on Bayer’s legacy of advancing standard-setting studies that have guided the management of thrombotic conditions across a range of disease states,” Sara Hegab, MD, VP, Stroke & Thrombosis, Specialty and Pipeline, U.S. Medical Affairs, Bayer, said in a statement.² “This foundational body of evidence reflects our continued commitment to rigorous science and is a class-defining contribution to the field of secondary stroke prevention. We are proud of this achievement and look forward to engaging with regulatory authorities to evaluate the potential role of asundexian for secondary stroke prevention.”

In the phase 3, double-blind OCEANIC-STROKE trial, patients in 72 hours of a noncardioembolic ischemic stroke or high-risk transient ischemic attack were randomly assigned to receive asundexian 50 mg once daily or placebo in addition to planned single or dual antiplatelet therapy. Participants had at least 1 of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque on cerebrovascular imaging. The primary efficacy outcome was ischemic stroke, and a key secondary outcome was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major bleeding, defined by the International Society on Thrombosis and Haemostasis (ISTH).

READ MORE: Breaking Down the 2026 Acute Ischemic Stroke Guidelines

Additional results demonstrated that the composite outcome of cardiovascular death, myocardial infarction, or stroke occurred in 568 patients (9.2%) in the asundexian group and 685 patients (11.1%) in the placebo group (cause-specific hazard ratio, 0.83; 95% CI, 0.74–0.92; P <.001). Furthermore, the composite of all-cause death, myocardial infarction, or stroke occurred in 649 patients (10.5%) in the asundexian group and 757 patients (12.3%) in the placebo group (cause-specific hazard ratio, 0.85; 95% CI, 0.77–0.95; P =.003).

All told, ISTH major bleeding occurred in 117 of 6124 patients (1.9%) in the asundexian group and 107 of 6130 patients (1.7%) in the placebo group (cause-specific hazard ratio, 1.10; 95% CI, 0.85–1.44; P = .46). Major or clinically relevant nonmajor bleeding occurred in 339 patients (5.5%) receiving asundexian and 307 patients (5.0%) receiving placebo (cause-specific hazard ratio, 1.12; 95% CI, 0.96–1.30; P = .16). Adverse events (AEs) were reported in 69.3% of patients in the asundexian group and 70.1% in the placebo group. Serious AEs occurred in 19.2% of patients receiving asundexian and 19.5% of those receiving placebo.

“Taken together, these findings support the broad generalizability of the trial results to the majority of patients with non-cardioembolic ischemic stroke or high-risk TIA encountered in clinical practice. This is further strengthened by the inclusion of patients with moderate-severe stroke severity up to an NIHSS of15 and those who received acute revascularization therapies, including intravenous thrombolysis or endovascular thrombectomy,” Shoamanesh told NeurologyLive.

Recently, co‑principal investigator of the OCEANIC-STROKE Mike Sharma, MD, MSc, presented the data as a late-breaking presentation at the 2026 International Stroke Conference (ISC), held February 4-6, in New Orleans, Louisiana.³ During the conference, Sharma, professor of medicine at McMaster University, spoke with NeurologyLive^® to further discuss the findings from the study. In the conversation, he emphasized the potential for asundexian to shift the paradigm in secondary stroke prevention by offering sustained benefit without the bleeding tradeoffs seen with other antithrombotic strategies.

Click here to view more of our stroke coverage.

REFERENCES
1. Sharma M, Dong Q, Hirano T, et al. Asundexian for Secondary Stroke Prevention. N Engl J Med. 2026;394(15):1467-1479. doi:10.1056/NEJMoa2513880
2. Statement on New England Journal of Medicine Publication of Phase III OCEANIC-STROKE Study Evaluating Asundexian. News release. Bayer. April 15, 2026. Accessed April 16, 2026. https://www.bayer.com/en/us/news-stories/statement-on-new-england-journal-of-medicine-publication-of-phase-iii-oceanic
3. Bayer’s asundexian demonstrated a substantial, 26 percent reduction in stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack with no increase in ISTH major bleeding versus placebo. News release. Bayer. February 5, 2026. Accessed April 16, 2026. https://www.bayer.com/media/en-us/bayers-asundexian-demonstrated-a-substantial-26-percent-reduction-in-stroke-after-a-non-cardioembolic-ischemic-stroke-or-high-risk-transient-ischemic-attack-with-no-increase-in-isth-major-bleeding-versus-placebo/