Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (AZALEA-TIMI 71)
Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (AZALEA-TIMI 71)
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 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: January 2023
Estimated Study Completion Date: May 2023
Arm:
- Experimental: Abelacimab (MAA868)
- Active Comparator: Rivaroxaban
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 1200 |
| Actual Study start date | 02 February 2021 |
| Estimated Study Completion Date | 01 May 2023 |