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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7508 | Experimental |
| |
| REGN9933 | Experimental |
| |
| Apixaban | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered per the protocol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any bleeding | Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding | 12 weeks | |
| Incidence of ISTH major bleeding | 12 weeks | |
| Incidence of ISTH CRNM bleeding |
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Key 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:
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:
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SEC Clinical Research | Recruiting | Dothan | Alabama | 36305 | United States | |
| Eastern Shore Research Institute |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| REGN9933 | Drug | Administered per the protocol |
|
|
| Apixaban | Drug | Administered per the protocol |
|
|
| 12 weeks |
| Incidence of minor bleeding | 12 weeks |
| Number of ISTH major bleeding events | 12 weeks |
| Number of ISTH CRNM bleeding events | 12 weeks |
| Number of minor bleeding events | 12 weeks |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Approximately 25 weeks |
| Severity of TEAEs | Approximately 25 weeks |
| Incidence of the composite of stroke or systemic embolism | Approximately 12 weeks |
| Incidence of Antidrug Antibodies (ADA) to REGN7508 | 12 weeks |
| Magnitude of ADA to REGN7508 | 12 weeks |
| Incidence of ADA to REGN9933 | 12 weeks |
| Magnitude of ADA to REGN9933 | 12 weeks |
| Concentrations of REGN7508 | Approximately 25 weeks |
| Concentrations of REGN9933 | Approximately 25 weeks |
| Change from baseline in activated Partial Thromboplastin Time (aPTT) | Approximately 25 weeks |
| Change from baseline in Prothrombin Time (PT) | Approximately 25 weeks |
| Recruiting |
| Fairhope |
| Alabama |
| 36532 |
| United States |
| Valley Clinical Trials, Inc | Recruiting | Covina | California | 91723 | United States |
| North Coast Cardiology | Recruiting | Encinitas | California | 92024 | United States |
| Mission Cardiovascular Research Institute | Recruiting | Fremont | California | 94538 | United States |
| National Institute of California Heart and Vein Specialists | Recruiting | Huntington Beach | California | 92648 | United States |
| Profound Research LLC at Southern California Heart Specialists | Recruiting | Pasadena | California | 91105 | United States |
| Empire Clinical Research | Recruiting | Pomona | California | 91767 | United States |
| Northbay Clinical Research Center | Recruiting | Santa Rosa | California | 95405 | United States |
| Cardiology Associates Medical Group | Recruiting | Ventura | California | 93003 | United States |
| Interventional Cardiology Medical Group | Recruiting | West Hills | California | 91307 | United States |
| Nouvelle Clinical Research LLC | Recruiting | Cutler Bay | Florida | 33189 | United States |
| South Florida Research Organization LLC | Recruiting | Medley | Florida | 33166 | United States |
| Inpatient Research Clinic LLC | Recruiting | Miami Lakes | Florida | 33014 | United States |
| Cardiovascular Center of Sarasota Foundation for Research and Education | Recruiting | Sarasota | Florida | 34239 | United States |
| Clinical Site Partners, LLC DBA Flourish Research | Recruiting | Winter Park | Florida | 32789 | United States |
| Health Sciences Research Building II | Recruiting | Atlanta | Georgia | 30322 | United States |
| NSC Research, Inc | Recruiting | Johns Creek | Georgia | 30024 | United States |
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Blue Coast Research Center, LLC | Recruiting | Indianapolis | Indiana | 46237 | United States |
| Franciscan Physician Network, Indiana Heart Physicians | Recruiting | Indianapolis | Indiana | 46237 | United States |
| Indiana Medical Research | Recruiting | Merrillville | Indiana | 46410 | United States |
| Reid Physician Associates | Recruiting | Richmond | Indiana | 47374 | United States |
| Monroe Research, LLC | Recruiting | West Monroe | Louisiana | 71291 | United States |
| Anderson Medical Research | Recruiting | Ft. Washington | Maryland | 20744 | United States |
| Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC) | Recruiting | Boston | Massachusetts | 02215 | United States |
| Profound Research, Millennium Cardiology | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| AA Medical Research Center (MRC) | Recruiting | Flint | Michigan | 48504 | United States |
| Fairview Health Services | Recruiting | Maplewood | Minnesota | 55109 | United States |
| Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research | Recruiting | Greensboro | North Carolina | 27401 | United States |
| K&R Research LLC | Recruiting | Marion | Ohio | 43302 | United States |
| Advanced Medical Research | Recruiting | Maumee | Ohio | 43537 | United States |
| Monument Health Clinical Research | Recruiting | Rapid City | South Dakota | 57701 | United States |
| East Coast Institute for Research, Jefferson City | Recruiting | Jefferson City | Tennessee | 37760 | United States |
| PharmaTex Research | Recruiting | Amarillo | Texas | 79106 | United States |
| Complete Heart Care P.A. | Recruiting | McKinney | Texas | 75071 | United States |
| Permian Research Foundation | Recruiting | Odessa | Texas | 79761 | United States |
| Tyler Cardiovascular Consultants | Recruiting | Tyler | Texas | 75701 | United States |
| Alpine Research TC | Recruiting | Clinton | Utah | 84015 | United States |
| Fundacion Estudios Clinicos - Cardiologia | Recruiting | Rosario | Santa Fe Province | 2000 | Argentina |
| STAT Research Argentina | Recruiting | Buenos Aires | 1060 | Argentina |
| Centro de Investigaciones Clinicas del Litoral - Cardiologia | Recruiting | Santa Fe | S3000FWO | Argentina |
| Hospital Ruy Azeredo | Recruiting | Goiânia | Goiás | 74453-200 | Brazil |
| Instituto de Cardiologia de Santa Catarina | Recruiting | São José | Santa Catarina | 88103-450 | Brazil |
| Instituto De Pesquisa Clinica de Campinas (Ipecc) | Recruiting | Campinas | São Paulo | 13060-080 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Centro Integrado de Pesquisa (CIP) | Recruiting | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| University of Alberta Hospital - Cardiology | Recruiting | Edmonton | Alberta | T6G 2G3 | Canada |
| Victoria Cardiac Arrhythmia Trials | Recruiting | Victoria | British Columbia | V8Z 0B9 | Canada |
| GA Research Associates Ltd. | Recruiting | Moncton | New Brunswick | E1G-1A7 | Canada |
| Health sciences North - Cardiology | Recruiting | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Hamilton Health Sciences Corporation | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
| Hamilton Medical Research Group (HMRG) | Recruiting | Hamilton | Ontario | L8L 5G4 | Canada |
| Dr James Cha | Recruiting | Oshawa | Ontario | L1J 2K1 | Canada |
| Heart Health Institute Research Inc. - Cardiology | Recruiting | Scarborough Village | Ontario | M1B 4Z8 | Canada |
| Viacar Recherches Cliniques Inc. - Cardiologie | Recruiting | Longueuil | Quebec | J4H 4B9 | Canada |
| Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Diex Recherche Inc. | Recruiting | Sherbrooke | Quebec | J1LOK3 | Canada |
| Diex Recherche Trois-rivieres | Recruiting | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| CHU de Quebec-Universite Laval | Recruiting | Québec | G1R 2J6 | Canada |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006470 | Hemorrhage |
| D020521 | Stroke |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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