drugset / Trial / NCT04755283
Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation
Phase 2
Active not recruiting
1287 enrolled
Anthos Therapeutics, Inc.
Novartis Pharmaceuticals · collab
RandomizedParallel-groupTriple-blindSupportive care
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.
Timeline
- Start
- 2021-02-02
- Primary completion
- 2024-02-15
- Completion
- 2028-12-29
Publications
- Results Ruff CT, Patel SM, Giugliano RP, Morrow DA, Hug B, Kuder JF, Goodrich EL, Chen SA, Goodman SG, Joung B, Kiss RG, Spinar J, Wojakowski W, Weitz JI, Murphy SA, Wiviott SD, Parkar S, Bloomfield D, Sabatine MS; AZALEA-TIMI 71 Investigators. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025 Jan 23;392(4):361-371. doi: 10.1056/NEJMoa2406674.
- Small AM, Patel SM, Giugliano RP, Morrow DA, Goodrich EL, Hug B, Parkar S, Chen SA, Goodman SG, Joung B, Kiss RG, Wojakowski W, Weitz JI, Bloomfield D, Sabatine MS, Ruff CT. Prior anticoagulation experience and bleeding risk with the factor XI inhibitor abelacimab in AZALEA-TIMI 71. Blood. 2026 May 29:blood.2026033829. doi: 10.1182/blood.2026033829. Online ahead of print.
- Al Said S, Patel SM, Giugliano RP, Morrow DA, Goodrich EL, Murphy SA, Hug B, Parkar S, Chen SA, Goodman SG, Joung B, Kiss RG, Wojakowski W, Weitz JI, Bloomfield D, Sabatine MS, Ruff CT. Abelacimab vs Rivaroxaban in Older Individuals With Atrial Fibrillation: A Prespecified Analysis of the Phase 2b AZALEA-TIMI 71 Trial. JAMA Cardiol. 2026 Mar 1;11(3):298-303. doi: 10.1001/jamacardio.2025.5418.
- Al Said S, Patel SM, Giugliano RP, Morrow DA, Goodrich EL, Murphy SA, Hug B, Parkar S, Chen SA, Goodman SG, Joung B, Kiss RG, Wojakowski W, Weitz JI, Bloomfield D, Sabatine MS, Ruff CT. Abelacimab Versus Rivaroxaban in Patients With Atrial Fibrillation on Antiplatelet Therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial. Circulation. 2025 Aug 5;152(5):290-296. doi: 10.1161/CIRCULATIONAHA.125.074037. Epub 2025 Jun 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abelacimab | Monoclonal antibody | 90 mg | Subcutaneous |
| Subject | Abelacimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Comparator | Rivaroxaban | Other / unclassified | 15 mg | Oral |
| Comparator | Rivaroxaban | Other / unclassified | 20 mg | Oral |