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)
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)
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:
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
clinicaltrials@regeneron.com844-734-6643
Huntington Beach, California 92648, United States
Pasadena, California 91105, United States
Sarasota, Florida 34239, United States
Winter Park, Florida 32789, United States
Indianapolis, Indiana 46237, United States
Boston, Massachusetts 02215, United States
Greensboro, North Carolina 27401, United States
Jefferson City, Tennessee 37760, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires 1060, Argentina
Belo Horizonte, Minas Gerais 30150-274, Brazil
Belo Horizonte, Minas Gerais 30220-140, Brazil
Poços de Caldas, Minas Gerais 37706-106, Brazil
Campinas, São Paulo 13060-904, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Scarborough Village, Ontario M1B 4Z8, Canada
Sherbrooke, Quebec J1H 5N4, Canada