completed

OCEANIC-STROKE is a multicenter, international, randomized, placebo controlled, double-blind, parallel group, event driven phase 3 study. The study treatment, asundexian, is a new type of anticoagulant that inhibits Factor XI and is currently under development to provide further treatment options and improve the standard of care with regard to the risk of bleeding.

The main purpose of this study is to learn whether adding asundexian to standard therapy reduces the risk of another stroke in participants who recently had a non-cardioembolic ischemic stroke or temporary stroke-like symptoms when given in addition to standard antiplatelet therapy.

OCEANIC-STROKE Findings
Study Type

Interventional - Drug

Study Design

Randomized, placebo controlled, double-blind, parallel group, event driven Phase 3 trial

NO. of Countries

37

NO. of Sites

703

NO. of Participants

12327

Study Period

2023 - 2025

Sponsor

Bayer

Mike Sharma (PI) addresses the OCEANIC‑STROKE trial hypothesis and outcomes, implications for secondary stroke prevention, safety across stroke subtypes, trial design and limitations, future directions for Factor XIa inhibitors, and anticipated regulatory timelines.

In an interview with HCPLive, Ashkan Shoamanesh (co-PI) discusses the groundbreaking findings from the OCEANIC‑STROKE trial and what they mean for cardiologists across specialties.

WSC 2025: Mike Sharma (PI) on OCEANIC-STROKE

WSC 2025: Mike Sharma (PI) on next steps in the research of Factor XIa inhibition for secondary stroke prevention: OCEANIC-STROKE

Back To Top