Status:
ACTIVE_NOT_RECRUITING
Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation
Lead Sponsor:
Anthos Therapeutics, Inc.
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Atrial Fibrillation (AF)
Stroke
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2028
Estimated Enrollment :
1287 Patients enrolled
Trial Details
Trial ID
NCT04755283
Start Date
February 2 2021
End Date
December 29 2028
Last Update
November 6 2025
Active Locations (92)
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1
Anthos Investigative Site
Huntsville, Alabama, United States, 35801
2
Anthos Investigative Site
Mobile, Alabama, United States, 36608
3
Anthos Investigative Site
Stamford, Connecticut, United States, 06905
4
Anthos Investigative Site
Clearwater, Florida, United States, 33756