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Набира участници Фаза 2 NCT07175428

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Atrial Fibrillation (AF)

Спонсор: Regeneron Pharmaceuticals

Налично на: БГ
Обобщение
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)
Кой може да участва
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 a Prothrombin Time/International Normalization Ratio (PT/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 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 Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Интервенции
REGN7508
DRUG
REGN9933
DRUG
Apixaban
DRUG
Места на провеждане 42
Канада (7)
Health sciences North - Cardiology
Greater Sudbury , Ontario
Viacar Recherches Cliniques Inc. - Cardiologie
Longueuil , Quebec
GA Research Associates Ltd.
Moncton , New Brunswick
Dr James Cha
Oshawa , Ontario
Heart Health Institute Research Inc. - Cardiology
Scarborough Village , Ontario
Diex Recherche Inc.
Sherbrooke , Quebec
Diex Recherche Trois-rivieres
Trois-Rivières , Quebec
САЩ (35)
PharmaTex Research
Amarillo , Texas
Health Sciences Research Building II
Atlanta , Georgia
Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)
Boston , Massachusetts
Alpine Research TC
Clinton , Utah
Nouvelle Clinical Research LLC
Cutler Bay , Florida
SEC Clinical Research
Dothan , Alabama
Eastern Shore Research Institute
Fairhope , Alabama
Profound Research LLC
Farmington Hills , Michigan
AA Medical Research Center (MRC)
Flint , Michigan
Mission Cardiovascular Research Institute
Fremont , California
Anderson Medical Research
Ft. Washington , Maryland
Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research
Greensboro , North Carolina
National Institute of California Heart and Vein Specialists
Huntington Beach , California
Indiana University
Indianapolis , Indiana
Blue Coast Research Center, LLC
Indianapolis , Indiana
Franciscan Physician Network, Indiana Heart Physicians
Indianapolis , Indiana
East Coast Institute for Research, Jefferson City
Jefferson City , Tennessee
NSC Research, Inc
Johns Creek , Georgia
K&R Research LLC
Marion , Ohio
Advanced Medical Research
Maumee , Ohio
Complete Heart Care P.A.
McKinney , Texas
Indiana Medical Research
Merrillville , Indiana
Inpatient Research Clinic LLC
Miami Lakes , Florida
Permian Research Foundation
Odessa , Texas
Profound Research LLC at Southern California Heart Specialists
Pasadena , California
Empire Clinical Research
Pomona , California
Monument Health Clinical Research
Rapid City , South Dakota
Reid Physician Associates
Richmond , Indiana
Northbay Clinical Research Center
Santa Rosa , California
Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota , Florida
Tyler Cardiovascular Consultants
Tyler , Texas
Cardiology Associates Medical Group
Ventura , California
Interventional Cardiology Medical Group
West Hills , California
Monroe Research, LLC
West Monroe , Louisiana
Clinical Site Partners, LLC DBA Flourish Research
Winter Park , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.10.2025
Крайна дата
21.04.2027
Регистрационен номер
NCT07175428
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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