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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Anthos Therapeutics, Inc.
- Enrollment
- 1,287
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- 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.
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •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
Arms & Interventions
Abelacimab 90 mg (MAA868)
Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly
Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
Intervention: Abelacimab (Biological)
Abelacimab 150 mg (MAA868)
Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly
Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
Intervention: Abelacimab (Biological)
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.
Intervention: Rivaroxaban (Drug)
Outcomes
Primary Outcomes
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
- Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events(Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.)
- Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events(Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.)