Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Recruiting · NCT07626411 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
- Meets one of the following:
- CHA2DS2-VA \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\] score ≥2 and Oral Anticoagulant (OAC) naïve OR
- CHA2DS2-VA score ≥3 OR
- CHA2DS2-VA score of 2 AND at least 1 enrichment criteria as described in the protocol
- Must have an International Normalized Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)
- Key
Exclusion criteria
- Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
- Has known moderate-to-severe mitral stenosis
- Has had a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization
- Had an ischemic stroke within 2 days prior to randomization
- Has persistent, uncontrolled hypertension (per investigator's discretion)
- Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Where it is running
32 locations listed across 15 US states.
- Advanced Cardiovascular - Alexander City, Alabama, United States
- SEC Clinical Research - Dothan, Alabama, United States
- Sun City Clinical Research - Glendale, Arizona, United States
- Mission Cardiovascular Research Institute - Fremont, California, United States
- Profound Research LLC at San Diego Cardiovascular Associates - La Jolla, California, United States
- Radin Cardiovascular Medical Group - Newport Beach, California, United States
- Valley Clinical Trials, LLC dba Flourish Research - Northridge, California, United States
- Southern California Heart Specialists - Pasadena, 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
- Sec Clinical Research - Pensacola, Florida, United States
- Cardiovascular Center of Sarasota Foundation for Research and Education - Sarasota, Florida, United States
- Atlanta Clinical Research Centers - Atlanta, Georgia, United States
- NSC Research, Inc - Johns Creek, Georgia, United States
- Profound Research, Powers Health Medical Group - Electrophysiology - Munster, Indiana, United States
- Monroe Research, LLC - West Monroe, Louisiana, United States
- Anderson Medical Research - Ft. Washington, Maryland, United States
- Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills - Bloomfield Hills, Michigan, United States
- Profound Research, Millennium Cardiology - Farmington Hills, Michigan, United States
- Super Health Pharmacy - Staten Island, New York, United States
- Hawthorne Health, Moose Pharmacy of Concord - Concord, North Carolina, United States
- K&R Research LLC - Marion, Ohio, United States
- Tennessee Center for Clinical Trials - Tullahoma, Tennessee, United States
- PharmaTex Research - Amarillo, Texas, United States
- PanAmerican Clinical Research - Brownsville, Texas, United States
- Synergy Groups Medical - Houston, Texas, United States
- West Houston Area Clinical Trial Consultants, LLC - Houston, Texas, United States
- Synergy Group Medical, LLC - Missouri City, Texas, United States
- Permian Research Foundation - Odessa, Texas, United States
- Carient Heart & Vascular - Manassas, Virginia, United States
- Conquest Research - Vienna, Virginia, United States