Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Recruiting · NCT07175428 · 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 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)
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 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Meets one of the following:
- CHA2DS2-VA \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\] 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 Normalization 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 successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
- Had an ischemic stroke within 2 days prior to randomization
- Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
- Has a history of central nervous system bleeding within 30 days prior to randomization
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Where it is running
60 locations listed across 16 US states.
- SEC Clinical Research - Dothan, Alabama, United States
- Eastern Shore Research Institute - Fairhope, Alabama, United States
- Valley Clinical Trials, Inc - Covina, California, United States
- North Coast Cardiology - Encinitas, California, 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
- The Cardiovascular Center - Redding, California, United States
- Northbay Clinical Research Center - Santa Rosa, 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
- South Florida Research Organization LLC - Medley, 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
- Grady Health System - Atlanta, Georgia, United States
- Health Sciences Research Building II - Atlanta, Georgia, United States
- NSC Research, Inc - Johns Creek, Georgia, United States
- Indiana University - Indianapolis, Indiana, United States
- Blue Coast Research Center, LLC - Indianapolis, Indiana, United States
- Franciscan Physician Network, Indiana Heart Physicians - Indianapolis, Indiana, United States
- Indiana Medical Research - Merrillville, 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
- Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC) - Boston, Massachusetts, United States
- Profound Research, Millennium Cardiology - Farmington Hills, Michigan, United States
- AA Medical Research Center (MRC) - Flint, Michigan, United States
- Fairview Health Services - Maplewood, Minnesota, United States
- Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research - Greensboro, North Carolina, United States
- K&R Research LLC - Marion, Ohio, United States
- Advanced Medical Research - Maumee, Ohio, United States
- Monument Health Clinical Research - Rapid City, South Dakota, United States
- East Coast Institute for Research, Jefferson City - Jefferson City, Tennessee, United States
- PharmaTex Research - Amarillo, Texas, United States
- Complete Heart Care P.A. - McKinney, Texas, United States
- Texas Institute of Cardiology PA - McKinney, Texas, United States
- Synergy Group Medical, LLC - Missouri City, Texas, United States
- Permian Research Foundation - Odessa, Texas, United States
- Tyler Cardiovascular Consultants - Tyler, Texas, United States
- Alpine Research TC - Clinton, Utah, United States
- STAT Research Argentina - Buenos Aires, Argentina
- Sanatorio Duarte Quiros - Córdoba, Argentina
- CHU de Quebec-Universite Laval - Québec, Canada
- Centro de Investigaciones Clinicas del Litoral - Santa Fe, Argentina
- Instituto Dante Pazanese de Cardiologia - São Paulo, Brazil
- University of Alberta Hospital - Cardiology - Edmonton, Alberta, Canada
- Victoria Cardiac Arrhythmia Trials - Victoria, British Columbia, Canada
- Centro de Investigacion Clinica - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Via Medica Research Center - Goiânia, Goiás, Brazil
- Hospital Ruy Azeredo - Goiânia, Goiás, Brazil
- Hospital das Clinicas da Universidade Federal de Goias - Goiânia, Goiás, Brazil
- Cardiologia Assistencial e de Pesquisa Ltda (Cardresearch) - Belo Horizonte, Minas Gerais, Brazil
- Nucleo de Pesquisa do Hospital Cardiologico Costantini (NUPEC) - Belo Horizonte, Minas Gerais, Brazil
- Hospital Maternidade e Pronto Socorro Santa Lucia - Poços de Caldas, Minas Gerais, Brazil
- GA Research Associates Ltd. - Moncton, New Brunswick, Canada
- Health sciences North - Cardiology - Greater Sudbury, Ontario, Canada
- Hamilton Health Sciences Corporation - Hamilton, Ontario, Canada
Showing 60 of 81 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →