OCEANIC-STROKE: Phase 3 study to investigate the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) compared with placebo in participants after an acute noncardioembolic ischemic stroke or high-risk TIA
Enrolling By Invitation
18-100 years
All
Phase
3
25 participants needed
1 Location
Brief description of study
The main purpose of this study is to learn
whether asundexian works better than placebo at reducing ischemic strokes in
participants who recently had a non-cardioembolic ischemic stroke or temporary
stroke-like symptoms when given in addition to standard antiplatelet
therapy. The
study treatment asundexian is a new type of anticoagulant currently under
development to provide further treatment options. It aims to further improve
the standard of care with regard to the risk of bleeding.
Detailed description of study
Dependent on the treatment group, the participants will
either take asundexian or placebo as tablets once a day for at least 3 months and up to 31 months.
Approximately every 3 months during the treatment period,
either a phone call or a visit to the study site is scheduled on an alternating
basis. In addition, one visit before and up to two visits after the treatment
period are planned.
During the study, the study team
will:
·
Check vital signs, such as blood pressure and heart
rate
·
Examine the participants' heart health using an
electrocardiogram (ECG)
·
Take blood samples
·
Ask the participants questions about how they are
feeling and what adverse events they are having.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Ischemic stroke, TIA
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion
- ≥ 18 years of age
- Acute non-cardioembolic stroke or high-risk transient ischemic attack (TIA)
- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
Exclusion
- Ischemic stroke ≤ 7 days before the index stroke event
- Index stroke following procedures or strokes due to other rare causes
- History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve, or other cardioembolic source of stroke requiring anticoagulation
Updated on
09 Mar 2024.
Study ID: 2023-28
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