IBREXIA-AF A Phase 3 Active-controlled Study of Milvexian for Prevention of Cardioembolic Events in Participants with Atrial Fibrillatio
- Conditions
- Atrial FibrillationMedDRA version: 20.0Level: PTClassification code: 10003658Term: Atrial fibrillation Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2022-501419-15-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15731
Minimum age of 18 years, Medically stable and appropriate for chronic antithrombotic treatment, Atrial fibrillation eligible to receive anticoagulation therapy., Participant must satisfy one or both of the following categories of risk factors (a or b): a. One or more of the following risk factors: i. Age =75 years ii. History of any type of stroke, including symptomatic stroke of any kind and silent brain infarcts or cerebral microbleeds b. Two or more of the following risk factors: i. Age between 65 and 74 years ii. Hypertension iii. Diabetes mellitus iv. Atherosclerotic vascular disease v. Heart Failure
Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study, Any condition other than AF that requires chronic anticoagulation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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