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Clinical Trials in South Korea / NCT04755283
Active, not recruiting Phase 2

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

NCT04755283 · tracked via the Priya Life Science South Korea 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)

Abelacimab →Rivaroxaban →

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
No
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)

FacilityCityRegionStatus
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 South Korea

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

AI-Powered Electrocardiography for Diagnosis and Prognostic Prediction in Cardiovascular Disease (AI-CVD): Multicenter Retrospective Study Recruiting
FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) Starting soon
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG Starting soon
Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation Starting soon
Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation 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 South Korea