A study of abelacimab in patients with atrial fibrillation deemed unsuitable for oral anticoagulation

JRCT ID: jRCT2031230045

Registered date:21/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial Fibrillation
• Date of first enrollment: 26/09/2023
• Target sample size: 125
• Countries of recruitment: Chile,Japan,China,Japan,Argentina,Japan,Bulgaria,Japan,Canada,Japan,Czech Republic,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Romania,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan,Brazil,Japan,Mexico,Japan,Estonia,Japan,Latvia,Japan,Lithuania,Japan
• Study type: Interventional
• Intervention(s): Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Outcome(s)

Primary Outcome

Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patient is able to understand and has provideded 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 4 OR age greater than or equal 75 and a CHA2DS2VASc greater than or equal 3
- Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
- 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
- Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study

Exclude criteria

- AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
- Patients who within 60 days prior to randomization (1) received a VKA (e.g., warfarin, phenprocoumon, acenocoumarol) or a DOAC such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
- 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

Related Information

• Primary Sponsor: Kinumura Takumi
• Secondary ID(s): NCT05712200