Study to gather information about the proper dosing of the oral FXIa inhibitor BAY 2433334 and to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with irregular heartbeat (atrial fibrillation).
- Conditions
- Atrial FibrillationMedDRA version: 20.0Level: PTClassification code 10053468Term: Anticoagulant therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-002365-35-SE
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
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
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) < 30 mL/min/1.73 m2, calculated by Modification of Diet in Renal Disease (MDRD) formula, determined between screening and randomization
9. Major surgery during the last 30 days or planned major surgery or intervention within study period (e.g. carotid endarterectomy, coronary artery bypass grafting)
10. Known allergy, intolerance or hypersensitivity to either of the study interventions (active substance or excipients)
11. Any contraindication for the use of an anticoagulant or listed in the local labeling for apixaban
12. Requirement for chronic anticoagulation (for a different indication than AF e.g. mechanical heart valve or cardiac thrombus) or antiplatelet therapy (up to 100 mg ASA is allowed). Anticipated need for chronic (more than 4 weeks) therapy with NSAIDs
13. Treated with a Vitamin K antagonist in the 30 days prior to screening
14. Concomitant use of any of the following therapies within 14 days (or at least five half-lives of the active substance whatever is longer) before randomization and first study intervention administration:
• Strong inhibitors of cytochrome P450 isoenzyme 3A4 (CYP3A4) e.g. human immunodeficiency virus protease inhibitors, systemically used azole-antimycotic agents, clarithromycin or telithromycin
• Strong inducers of CYP3A4, e.g. phenytoin, carbamazepine, phenobarbital, rifampicin or St. John’s wort.
15. Women of childbearing potential (women are considered of childbearing potential if they are not surgically sterile or postmenopausal, defined as amenorrhea for >?12 months). Male participants not willing to use condoms when sexually active with a woman of childbearing potential
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