Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (AZALEA-TIMI 71)
Atrial Fibrillation (AF), Stroke
About this trial
This is an interventional supportive care trial for Atrial Fibrillation (AF) focused on measuring randomized, prospective, blinded endpoint evaluation, abelacimab, MAA868, rivaroxaban, atrial fibrillation, Factor XI, stroke, bleeding events, anti-coagulant, anticoagulation therapy
Eligibility Criteria
Inclusion Criteria:
- Male and female patients ≥ 55 years old
- Patients with a history of atrial fibrillation (AF) or atrial flutter with planned indefinite anticoagulation
Patients with a CHA2DS2-VASc of ≥4 OR a CHA2DS2-VASc of ≥3 with at least 1 of the following:
- Planned concomitant use of antiplatelet medication use (i.e., aspirin and/or P2Y12 inhibitor) for the duration of the trial
- Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation
Exclusion Criteria:
- History of hypersensitivity to any of the study drugs (including rivaroxaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for rivaroxaban
- Patients with an intracranial or intraocular bleed within the 3 months prior to screening
- Clinically significant mitral stenosis (valve area <1.5 cm2)
- Mechanical heart valve or other indication for anticoagulation therapy other than atrial fibrillation (e.g., venous thromboembolism)
- Known presence of an atrial myxoma or left ventricular thrombus
- History of left atrial appendage closure or removal
- Active endocarditis
Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site (4002)
- Anthos Investigative Site (4003)
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
- Anthos Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Abelacimab (MAA868)
Rivaroxaban
Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly
Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Patients with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily.