OCEANIC-STROKE

Full Name

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years or older after an acute non-cardioembolic ischemic stroke or high-risk TIA

Description

The study medication, asundexian, an oral medication, is expected to show benefit in reducing the risk of stroke in individuals who have had a previous stroke or TIA. At the same time, asundexian is expected to have low risk of bleeding. This expected benefit has been seen from completed previous clinical studies. Individuals interested in the study will be asked to take the medication over a 27 month period, in which further follow up will be completed.

Purpose

The purpose of the study is to evaluate whether asundexian is effective at reducing ischemic stroke in patients after an ischemic stroke or TIA on top of background antiplatelet therapy.

Eligibility

Inclusion Criteria