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

Running, not enrolling · Phase 2

Conditions studied: Atrial Fibrillation (AF), Stroke

In brief

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.

Key facts

Study ID

NCT04755283

Run by

Anthos Therapeutics, Inc.

People needed

1287

Starts

2021-02-02

Expected to finish

2028-12-29

Last updated by the study team

2025-11-06

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anthos Investigative Site — Mobile, Alabama, United States
• Anthos Investigative Site — Stamford, Connecticut, United States
• Anthos Investigative Site — Clearwater, Florida, United States
• Anthos Investigative Site — Daytona Beach, Florida, United States
• Anthos Investigative Site — Largo, Florida, United States
• Anthos Investigative Site — Safety Harbor, Florida, United States
• Anthos Investigative Site — Saint Augustine, Florida, United States
• Anthos Investigative Site — Johns Creek, Georgia, United States
• Anthos Investigative Site — Owensboro, Kentucky, United States
• Anthos Investigative Site — Baltimore, Maryland, United States
• Anthos Investigative Site — Salisbury, Maryland, United States
• Anthos Investigative Site — Framingham, Massachusetts, United States
• Anthos Investigative Site — Haverhill, Massachusetts, United States
• Anthos Investigative Site — Lansing, Michigan, United States
• Anthos Investigative Site — Sewell, New Jersey, United States
• Anthos Investigative Site — Poughkeepsie, New York, United States
• Anthos Investigative Site — Southampton, New York, United States
• Anthos Investigative Site — Lenoir, North Carolina, United States
• Anthos Investigative Site — Fargo, North Dakota, United States
• Anthos Investigative Site — Oklahoma City, Oklahoma, United States
• Anthos Investigative Site — Camp Hill, Pennsylvania, United States
• Anthos Investigative Site — Kingsport, Tennessee, United States
• Anthos Investigative Site — Kingwood, Texas, United States
• Anthos Investigative Site — Odessa, Texas, United States
• Anthos Investigative Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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