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.

Brief description of study

OCEANIC-STROKE (study 20604) is a multicenter, international, randomized, placebo controlled, double-blind, parallel group, event driven phase 3 study. The purpose of this study is to investigate the efficacy of the oral FXIa inhibitor asundexian in prevention of ischemic stroke and its safety (bleeding) compared with placebo on top of background antiplatelet therapy in adult participants after an acute non-cardioembolic ischemic stroke or high-risk TIA.

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