A study of abelacimab in patients with atrial fibrillation deemed unsuitable for oral anticoagulatio
- Conditions
- Atrial Fibrillation
- Registration Number
- JPRN-jRCT2031230045
- Lead Sponsor
- Tsurumaki Sachi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 125
Patient is able to understand and willing to provide written informed consent to participate in the trial
- Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
- Age 65-74 and a CHA2DS2VASc greater than or equal to 5 OR agegreater than or equal to 75 and a CHA2DS2VASc greater than or equal to 4
- Judged by the responsible physician or by their own decision to be unsuitable for oral anticoagulation
- At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls
- AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
- Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 60 days prior to randomization
- Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
- Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
- Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method