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

NCT04755283 · tracked via the Priya Life Science USA tracker

Sponsor

Anthos Therapeutics, Inc.

Phase

Phase 2

Started

2021-02-02

Last updated

2025-11-06

Condition(s) studied

Atrial Fibrillation (AF)Stroke

Investigational drug(s) / intervention(s)

AbelacimabRivaroxaban

Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)

Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets

Study 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.

Eligibility

Sex

ALL

Min age

55 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events — Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
The number of participants experiencing the first occurrence of the composite of ISTH-defined major bleeding or CRNM bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

Trial sites (92)

Facility	City	Region
Anthos Investigative Site	Huntsville	Alabama
Anthos Investigative Site	Mobile	Alabama
Anthos Investigative Site	Stamford	Connecticut
Anthos Investigative Site	Clearwater	Florida
Anthos Investigative Site	Daytona Beach	Florida
Anthos Investigative Site	Largo	Florida
Anthos Investigative Site	Safety Harbor	Florida
Anthos Investigative Site	Saint Augustine	Florida
Anthos Investigative Site	Johns Creek	Georgia
Anthos Investigative Site	Owensboro	Kentucky
Anthos Investigative Site	Baltimore	Maryland
Anthos Investigative Site	Salisbury	Maryland
Anthos Investigative Site	Framingham	Massachusetts
Anthos Investigative Site	Haverhill	Massachusetts
Anthos Investigative Site	Lansing	Michigan
Anthos Investigative Site	Sewell	New Jersey
Anthos Investigative Site	Poughkeepsie	New York
Anthos Investigative Site	Southampton	New York
Anthos Investigative Site	Lenoir	North Carolina
Anthos Investigative Site	Fargo	North Dakota
Anthos Investigative Site	Oklahoma City	Oklahoma
Anthos Investigative Site	Camp Hill	Pennsylvania
Anthos Investigative Site	Kingsport	Tennessee
Anthos Investigative Site	Kingwood	Texas
Anthos Investigative Site	Odessa	Texas
Anthos Investigative Site	Tomball	Texas
Anthos Investigative Site	Falls Church	Virginia
Anthos Investigative Site	Manassas	Virginia
Anthos Investigative Site	Cambridge	Ontario
Anthos Investigative Site	Greater Sudbury	Ontario
Anthos Investigative Site	Oshawa	Ontario
Anthos Investigative Site	Greenfield Park	Quebec
Anthos Investigative Site	Montreal	Quebec
Anthos Investigative Site	Brandýs nad Labem	Central Bohemia
Anthos Investigative Site	Poděbrady	Central Bohemia
Anthos Investigative Site	Příbram	Central Bohemia
Anthos Investigative Site	Slaný	Central Bohemia
Anthos Investigative Site	Mariánské Lázně	KA
Anthos Investigative Site	Trutnov	KR
Anthos Investigative Site	Liberec	LB

+ 52 more sites — see the full list on the official registry below.

On this site

📄 Xarelto (rivaroxaban) drug profile →

More Anthos Therapeutics, Inc. trials in the USA

Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76) Recruiting

Other trials for the same condition

Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation Recruiting

Pilot/Pivotal Study of DBS+Rehab After Stroke Recruiting

Traumatic Brain Injury and Stroke Long Term Outcome Recruiting

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable Recruiting

SIMPLAAFY Clinical Trial Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04755283 on ClinicalTrials.gov ↗ ← All trials in the USA