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Active, Not Recruiting

NCT Number: NCT04755283

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anthos Investigative Site, Cambridge, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

Abelacimab

Biological

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

Other names: MAA868

Rivaroxaban

Drug

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

Primary outcomes

  1. 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

    Time frame: 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.

Secondary outcomes

  1. Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events

    Time frame: 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 ISTH-defined major 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.

  2. Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events

    Time frame: 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 or CRNM or minor 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.

Sponsors and collaborators

Lead sponsor

Anthos Therapeutics, Inc.

Industry

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared With Open-Label Rivaroxaban in Patients With Atrial Fibrillation (AZALEA)

Acronym: AZALEA-TIMI 71

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Feb 16, 2021
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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