Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the ANT-006 study is to evaluate the bleeding profile of abelacimab relative to rivaroxaban in patients with atrial fibrillation (AF) at moderate-to-high risk of stroke.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthos Therapeutics, Inc.
• Collaborators: Covance; The TIMI Study Group
• Treatments: Rivaroxaban

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:

1. Planned concomitant use of antiplatelet medication use (i.e., aspirin and/or P2Y12 inhibitor) for the duration of the trial

2. 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

• 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