A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 a Prothrombin Time/International Normalization Ratio (PT/INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)
Locations
United States
Alabama
SEC Clinical Research
RECRUITING
Dothan
Eastern Shore Research Institute
RECRUITING
Fairhope
California
Mission Cardiovascular Research Institute
RECRUITING
Fremont
National Institute of California Heart and Vein Specialists
RECRUITING
Huntington Beach
Profound Research LLC at Southern California Heart Specialists
RECRUITING
Pasadena
Empire Clinical Research
RECRUITING
Pomona
Northbay Clinical Research Center
RECRUITING
Santa Rosa
Cardiology Associates Medical Group
RECRUITING
Ventura
Interventional Cardiology Medical Group
RECRUITING
West Hills
Florida
Nouvelle Clinical Research LLC
RECRUITING
Cutler Bay
Inpatient Research Clinic LLC
RECRUITING
Miami Lakes
Cardiovascular Center of Sarasota Foundation for Research and Education