New blood thinners aim to cut stroke risk with fewer bleeding side effects
NCT ID NCT07175428
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 10 times
Summary
This study tests two experimental drugs, REGN7508 and REGN9933, in about 1,200 people with atrial fibrillation (an irregular heartbeat). The goal is to see if these drugs can prevent blood clots and strokes with less bleeding compared to the standard blood thinner apixaban. Participants will receive one of the study drugs or apixaban, and researchers will monitor bleeding events and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 an International Normalization Ratio (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 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 6. Has a history of central nervous system bleeding within 30 days prior to randomization Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
80 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AA Medical Research Center (MRC)
RECRUITINGFlint, Michigan, 48504, United States
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Advanced Medical Research
RECRUITINGMaumee, Ohio, 43537, United States
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Alpine Research TC
RECRUITINGClinton, Utah, 84015, United States
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Anderson Medical Research
RECRUITINGFt. Washington, Maryland, 20744, United States
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Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)
RECRUITINGBoston, Massachusetts, 02215, United States
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Blue Coast Research Center, LLC
RECRUITINGIndianapolis, Indiana, 46237, United States
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CHU de Quebec-Universite Laval
RECRUITINGQuébec, G1R 2J6, Canada
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CISSS du Bas-Saint-Laurent - Hopital regional de Rimouski - Cardiologie
RECRUITINGRimouski, Quebec, G5L 5T1, Canada
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Cardiologia Assistencial e de Pesquisa Ltda (Cardresearch)
RECRUITINGBelo Horizonte, Minas Gerais, 30150-274, Brazil
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Cardiology Associates Medical Group
RECRUITINGVentura, California, 93003, United States
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Cardiovascular Center of Sarasota Foundation for Research and Education
RECRUITINGSarasota, Florida, 34239, United States
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Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie
RECRUITINGSherbrooke, Quebec, J1H 5N4, Canada
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Centro De Pesquisa Clinica Do Coracao
RECRUITINGAracaju, Sergipe, 49055-530, Brazil
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Centro de Estudos Procardio
RECRUITINGBlumenau, Santa Catarina, 89010-022, Brazil
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Centro de Investigacion Clinica
RECRUITINGCiudad Autonoma de Buenos Aires, Buenos Aires, 1060, Argentina
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Centro de Investigaciones Clinicas del Litoral
RECRUITINGSanta Fe, S3000FWO, Argentina
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Clinical Site Partners, LLC DBA Flourish Research
RECRUITINGWinter Park, Florida, 32789, United States
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Complete Heart Care P.A.
RECRUITINGMcKinney, Texas, 75071, United States
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Diex Recherche Inc.
RECRUITINGSherbrooke, Quebec, J1LOK3, Canada
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Diex Recherche Trois-rivieres
RECRUITINGTrois-Rivières, Quebec, G9A 4P3, Canada
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Dr James Cha
RECRUITINGOshawa, Ontario, L1J 2K1, Canada
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East Coast Institute for Research, Jefferson City
RECRUITINGJefferson City, Tennessee, 37760, United States
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Eastern Shore Research Institute
RECRUITINGFairhope, Alabama, 36532, United States
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Empire Clinical Research
RECRUITINGPomona, California, 91767, United States
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Faculdade de Medicina de Botucatu (UNESP)
RECRUITINGBotucatu, São Paulo, 18618-687, Brazil
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Fairview Health Services
RECRUITINGMaplewood, Minnesota, 55109, United States
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Franciscan Physician Network, Indiana Heart Physicians
RECRUITINGIndianapolis, Indiana, 46237, United States
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Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Centro Integrado de Pesquisa (CIP)
RECRUITINGSão José do Rio Preto, São Paulo, 15090-000, Brazil
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Fundacion Estudios Clinicos
RECRUITINGRosario, Santa Fe Province, 2000, Argentina
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GA Research Associates Ltd.
RECRUITINGMoncton, New Brunswick, E1G-1A7, Canada
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Grady Health System
RECRUITINGAtlanta, Georgia, 30303, United States
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Hamilton Health Sciences Corporation
RECRUITINGHamilton, Ontario, L8L 2X2, Canada
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Hamilton Medical Research Group (HMRG)
RECRUITINGHamilton, Ontario, L8L 5G4, Canada
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Health Sciences Research Building II
WITHDRAWNAtlanta, Georgia, 30322, United States
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Health sciences North - Cardiology
RECRUITINGGreater Sudbury, Ontario, P3E 5J1, Canada
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Heart Health Institute Research Inc. - Cardiology
RECRUITINGScarborough Village, Ontario, M1B 4Z8, Canada
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Hospital Ernesto Dornelles
RECRUITINGPorto Alegre, Rio Grande do Sul, 90160-092, Brazil
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Hospital Maternidade e Pronto Socorro Santa Lucia
RECRUITINGPoços de Caldas, Minas Gerais, 37706-106, Brazil
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Hospital Ruy Azeredo
RECRUITINGGoiânia, Goiás, 74453-200, Brazil
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Hospital da Pontificia Universidade Catolica (PUC) Campinas
RECRUITINGCampinas, São Paulo, 13060-904, Brazil
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Hospital das Clinicas da Universidade Federal de Goias
RECRUITINGGoiânia, Goiás, 74605-050, Brazil
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Indiana Medical Research
RECRUITINGMerrillville, Indiana, 46410, United States
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Indiana University
RECRUITINGIndianapolis, Indiana, 46202, United States
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Inpatient Research Clinic LLC
RECRUITINGMiami Lakes, Florida, 33014, United States
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Instituto Dante Pazanese de Cardiologia
RECRUITINGSão Paulo, 04012-909, Brazil
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Instituto De Pesquisa Clinica de Campinas (Ipecc)
RECRUITINGCampinas, São Paulo, 13060-080, Brazil
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Instituto de Cardiologia de Santa Catarina
RECRUITINGSão José, Santa Catarina, 88103-450, Brazil
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Interventional Cardiology Medical Group
RECRUITINGWest Hills, California, 91307, United States
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K&R Research LLC
RECRUITINGMarion, Ohio, 43302, United States
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Mission Cardiovascular Research Institute
RECRUITINGFremont, California, 94538, United States
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Monroe Research, LLC
RECRUITINGWest Monroe, Louisiana, 71291, United States
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Monument Health Clinical Research
RECRUITINGRapid City, South Dakota, 57701, United States
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Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research
RECRUITINGGreensboro, North Carolina, 27401, United States
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NSC Research, Inc
RECRUITINGJohns Creek, Georgia, 30024, United States
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National Institute of California Heart and Vein Specialists
RECRUITINGHuntington Beach, California, 92648, United States
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North Coast Cardiology
RECRUITINGEncinitas, California, 92024, United States
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Northbay Clinical Research Center
RECRUITINGSanta Rosa, California, 95405, United States
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Nouvelle Clinical Research LLC
RECRUITINGCutler Bay, Florida, 33189, United States
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Nucleo de Pesquisa Clínica SS
RECRUITINGCuritiba, Paraná, 80730-150, Brazil
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Nucleo de Pesquisa do Hospital Cardiologico Costantini (NUPEC)
RECRUITINGBelo Horizonte, Minas Gerais, 30220-140, Brazil
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Permian Research Foundation
RECRUITINGOdessa, Texas, 79761, United States
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PharmaTex Research
RECRUITINGAmarillo, Texas, 79106, United States
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Pontificia Universidade Catolica do Paraná (PUC) Trials
RECRUITINGCuritiba, Paraná, 80230-130, Brazil
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Profound Research LLC at Southern California Heart Specialists
RECRUITINGPasadena, California, 91105, United States
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Profound Research, Millennium Cardiology
RECRUITINGFarmington Hills, Michigan, 48334, United States
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Quanta Diagnostico por Imagem
RECRUITINGCuritiba, Paraná, 80045-110, Brazil
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Reid Physician Associates
RECRUITINGRichmond, Indiana, 47374, United States
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SEC Clinical Research
RECRUITINGDothan, Alabama, 36305, United States
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STAT Research Argentina
RECRUITINGBuenos Aires, 1060, Argentina
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Sanatorio Duarte Quiros
RECRUITINGCórdoba, 5002, Argentina
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Sociedade Hospitalar Angelina Caron
RECRUITINGCampina Grande do Sul, Paraná, 83430-973, Brazil
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South Florida Research Organization LLC
RECRUITINGMedley, Florida, 33166, United States
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Synergy Group Medical, LLC
RECRUITINGMissouri City, Texas, 77459, United States
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Texas Institute of Cardiology PA
RECRUITINGMcKinney, Texas, 75071, United States
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The Cardiovascular Center
RECRUITINGRedding, California, 96001, United States
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Tyler Cardiovascular Consultants
RECRUITINGTyler, Texas, 75701, United States
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University of Alberta Hospital - Cardiology
RECRUITINGEdmonton, Alberta, T6G 2G3, Canada
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Valley Clinical Trials, Inc
RECRUITINGCovina, California, 91723, United States
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Via Medica Research Center
RECRUITINGGoiânia, Goiás, 74223-130, Brazil
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Viacar Recherches Cliniques Inc. - Cardiologie
RECRUITINGLongueuil, Quebec, J4H 4B9, Canada
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Victoria Cardiac Arrhythmia Trials
RECRUITINGVictoria, British Columbia, V8Z 0B9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Can a breathing workout and walks help dialysis patients with irregular heartbeats?
- Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?
- Can a new mapping and ablation system fix recurring atrial fibrillation?
- Can shedding pounds stop atrial fibrillation in its tracks?
- Pacemaker algorithm tuned to Heart's pumping may beat standard rate response