The purpose of this study is to learn if asundexian is safe for the participants, how it affects the body, and to look at how well it works to prevent future ischemic strokes in participants who already had had an acute non-cardioembolic ischemic stroke or high-risk TIA.
OCEANIC-STROKE
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 and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
Ischemic stroke, Transient ischemic attack
All genders
18+
Recruiting now
Overview
Principal Investigator: Dr. Emiliya Melkumova
Contact Us
Nikolas Melkumyan
Study details
Inclusion Criteria
- 18 years of age or older at time of signing the informed consent.
- Participants with non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
- Able to randomize within 72 hours after the onset of symptoms of the index event.
Exclusion Criteria
- Recent ischemic stroke within 7 days before index stroke event.
- Known premorbid mRS greater than 4.
- History of atrial fibrillation/flutter, left ventricular thrombus, mechanical valve, or other cardioembolic sources of stroke requiring anticoagulation.
Study Requirements
There will be a screening visit followed by a randomization visit within 72 hours of the onset of symptoms of the index event (stroke or TIA). There will be 8 on-site visits during this study. Each visit is expected to take around one hour to complete and will be performed in the Neurology clinic at Tufts Medical Center. At these visits, vitals, an ECG, blood draws, and questionnaires will be performed. You will also be contacted up to 6 times through telephone calls to assess disability status and any recent health changes. These phone calls are expected to take up to five minutes in total and will be performed between the on-site visits. We expect that you will be in this research study for up to 31 months, depending on when you enter the study.