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

Phase 2

Active, not recruiting

• Conditions: Atrial Fibrillation (AF); Stroke
• Interventions: Biological: Abelacimab; Drug: Rivaroxaban

• Registration Number: NCT04755283
• Lead Sponsor: Anthos Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-16
• Primary Completion: 2024-02-15
• Disposition First Posted: 2025-01-23
• Disposition First Submitted: 2025-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1287

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abelacimab (MAA868)	Abelacimab	Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
Rivaroxaban	Rivaroxaban	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.

Primary Outcome Measures

Name	Time	Method
Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events	From randomization through study completion, an average of 17 months	Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events

Secondary Outcome Measures

Name	Time	Method
Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events	From randomization through study completion, an average of 17 months	Time to first event ISTH-defined major or minor bleeding events
Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events	From randomization through study completion, an average of 17 months	Time to first event ISTH-defined major bleeding events

Trial Locations

Locations (3)

Anthos Investigative Site; 🇨🇳 Tiachung, TXG, Taiwan

Anthos Investigative Site (4002); 🇭🇺 Nyíregyháza, SZ, Hungary

Anthos Investigative Site (4003); 🇭🇺 Nyíregyháza, SZ, Hungary