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Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (AZALEA-TIMI 71)

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ClinicalTrials.gov Identifier: NCT04755283
Recruitment Status : Active, not recruiting
First Posted : February 16, 2021
Last Update Posted : November 13, 2023
Sponsor:
Collaborators:
The TIMI Study Group
Laboratory Corporation of America
Information provided by (Responsible Party):
Anthos Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation (AF) Stroke Biological: Abelacimab Drug: Rivaroxaban Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open-label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All care providers are blinded with the exception of the pharmacist and study team member assigned to administer the subcutaneous injection of abelacimab.
Primary Purpose: Supportive Care
Official 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)
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Abelacimab (MAA868)

Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly

Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly

 Biological: Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
Other Name: MAA868
Active Comparator: 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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events [ Time Frame: 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 :
  1. Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events [ Time Frame: From randomization through study completion, an average of 17 months ]
    Time to first event ISTH-defined major bleeding events

  2. Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events [ Time Frame: From randomization through study completion, an average of 17 months ]
    Time to first event ISTH-defined major or minor bleeding events


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755283


Locations
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Sponsors and Collaborators
Anthos Therapeutics, Inc.
The TIMI Study Group
Laboratory Corporation of America
More Information
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Responsible Party: Anthos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04755283    
Other Study ID Numbers: ANT-006
2020-004507-13 ( EudraCT Number )
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthos Therapeutics, Inc.:
randomized
prospective
blinded endpoint evaluation
abelacimab
MAA868
rivaroxaban
 atrial fibrillation
Factor XI
stroke
bleeding events
anti-coagulant
anticoagulation therapy
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Rivaroxaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants