Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation (ROXI-ATLAS)

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Atrial Fibrillation (AF)

Treatments: Drug: REGN7508; Drug: REGN9933; Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT07175428

R7508-CVA-2393

Details and patient eligibility

About

This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.

The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.

The study is looking at several other research questions, including:

• What side effects may happen from taking REGN7508 or REGN9933
• How well do the study drugs reduce the risk of having a stroke
• How much of REGN7508 or REGN9933 is in the blood at different times
• Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol

2. Meets one of the following:

   1. CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years] score ≥2 and Oral Anticoagulant (OAC) naïve or
   2. CHA2DS2-VA score ≥3 or
   3. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol

3. Must have a Prothrombin Time/International Normalization Ratio (PT/INR) <2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

Key Exclusion Criteria:

1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
2. Has known moderate-to-severe mitral stenosis
3. Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
4. Had an ischemic stroke within 2 days prior to randomization
5. Has Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 14 days prior to randomization or on dialysis or expected to be started as described in the protocol
6. Has a history of central nervous system bleeding within 30 days prior to randomization

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 3 patient groups

REGN7508

Experimental group

Treatment:

Drug: REGN7508

REGN9933

Experimental group

Treatment:

Drug: REGN9933

Apixaban

Active Comparator group

Treatment:

Drug: Apixaban