Atrial Fibrillation MedDRA version: 20.0 Level: PT Classification code 10053468 Term: Anticoagulant therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 45 years of age or older at the time of signing the informed consent. 2. Participant with AF documented by ECG evidence with • CHA2DS2-VASc score =?2 if male or CHA2DS2-VASc score =?3 if female • Indication for treatment with an oral anticoagulant in • any participant currently not treated with an oral anticoagulant (e.g. treatment naïve) or alternatively, • participant on a NOAC in case of at least one bleeding risk feature (history of a prior bleed within the last 12 months requiring medical attention and?/?or moderate renal dysfunction with eGFR 30-50 ml/min and?/?or current clinically indicated antiplatelet therapy with ASA = 100 mg) 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: 1. Mechanical heart valve prosthesis 2. Any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral stenosis 3. Atrial fibrillation due to a reversible cause, participants in sinus rhythm after successful ablation, or plan for cardioversion or ablation during study conduct 4. Stroke within the last 30 days of screening 5. Uncontrolled hypertension (systolic blood pressure =?160 mmHg or diastolic blood pressure =?100 mmHg) at randomization 6. Active bleeding; known bleeding disorder 7. Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or hepatic insufficiency classified as Child-Pugh B or C, or ALT/AST >?2.5 x the upper limit of normal, measured between screening and randomization 8. Estimated glomerular filtration rate (eGFR) ?12 months). Male participants not willing to use condoms when sexually active with a woman of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate that the oral FXIa inhibitor BAY 2433334 when compared to apixaban leads to a lower incidence of bleeding in participants with AF;Secondary Objective: Not applicable;Primary end point(s): Composite of ISTH major and clinically relevant non-major bleeding;Timepoint(s) of evaluation of this end point: From Visit 2 (randomization visit) until Visit 7 (safety follow-up visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Safety Endpoints: • All bleeding • ISTH major bleeding • ISTH clinically relevant non-major bleeding • ISTH minor bleeding ;Timepoint(s) of evaluation of this end point: From Visit 2 (randomization visit) until Visit 7 (safety follow-up visit) | — |
Countries
Austria, Belgium, Canada, Czech Republic, France, Hungary, Italy, Japan, Latvia, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer
Outcome results
None listed