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

Anthos Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Stroke; Atrial Fibrillation (AF)

Treatments: Drug: Rivaroxaban; Biological: Abelacimab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04755283

2020-004507-13 (EudraCT Number)

ANT-006

Details and patient eligibility

About

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.

Enrollment: 1,287 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,287 participants in 2 patient groups

Abelacimab (MAA868)

Experimental group

Description:

Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly

Treatment:

Biological: Abelacimab

Rivaroxaban

Active Comparator group

Description:

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.

Treatment:

Drug: Rivaroxaban