Last updated 12 days ago
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
1200 patients around the world
Available in United States, Brazil, Argentina
Regeneron Pharmaceuticals
5Research sites
1200Patients around the world
This study is for people with
Cardiac arrhythmia
Atrial fibrillation
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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).
- 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.
Sites
STAT Research - CABA
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Centro de Investigaciones Clínicas del Litoral SRL
Recruiting
Instituto De Pesquisa Clinica de Campinas - Ipecc
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
StudyROXI-ATLAS
SponsorRegeneron Pharmaceuticals
Study typeInterventional
Conditions
Atrial fibrillation
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07175428
