EUCTR2022-000758-28-BEActive, not recruitingPhase 1
A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke - Oral faCtor Eleven A iNhibitor asundexIan as novel antithrombotiC - AF study
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer AG
- Enrollment
- 18,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
- •2. Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
- •3. CHA2DS2-VASc score = 3 if male or = 4 if female,
- •CHA2DS2-VASc score of 2 if male or 3 if female and
- •enrichment criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12000
Exclusion Criteria
- •1. Mechanical heart valve prosthesis
- •2. Moderate-to-severe mitral stenosis at the time of inclusion into the study
- •3. Atrial fibrillation only due to reversible cause
- •4. Requirement for chronic anticoagulation for a different indication than atrial fibrillation
Investigators
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