Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
NCT ID: NCT07175428
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
1200 participants
INTERVENTIONAL
2025-10-20
2027-04-21
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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REGN7508
REGN7508
Administered per the protocol
REGN9933
REGN9933
Administered per the protocol
Apixaban
Apixaban
Administered per the protocol
Interventions
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REGN7508
Administered per the protocol
REGN9933
Administered per the protocol
Apixaban
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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SEC Clinical Research
Dothan, Alabama, United States
Eastern Shore Research Institute
Fairhope, Alabama, United States
Mission Cardiovascular Research Institute
Fremont, California, United States
National Institute of California Heart and Vein Specialists
Huntington Beach, California, United States
Profound Research LLC at Southern California Heart Specialists
Pasadena, California, United States
Empire Clinical Research
Pomona, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
Nouvelle Clinical Research LLC
Cutler Bay, Florida, United States
Inpatient Research Clinic LLC
Miami Lakes, Florida, United States
Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota, Florida, United States
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, United States
NSC Research, Inc
Johns Creek, Georgia, United States
Blue Coast Research Center, LLC
Indianapolis, Indiana, United States
Franciscan Physician Network, Indiana Heart Physicians
Indianapolis, Indiana, United States
Reid Physician Associates
Richmond, Indiana, United States
Monroe Research, LLC
West Monroe, Louisiana, United States
Anderson Medical Research
Ft. Washington, Maryland, United States
Profound Research LLC
Farmington Hills, Michigan, United States
AA Medical Research Center (MRC)
Flint, Michigan, United States
K&R Research LLC
Marion, Ohio, United States
East Coast Institute for Research, Jefferson City
Jefferson City, Tennessee, United States
PharmaTex Research
Amarillo, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Alpine Research TC
Clinton, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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R7508-CVA-2393
Identifier Type: -
Identifier Source: org_study_id
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