Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation
Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.
Inclusion Criteria:
Participant must be 45 years of age or older at the time of signing the informed consent.
Participant with AF documented by ECG evidence with
CHA2DS2-VASc score ≥ 2 if male or CHA2DS2-VASc score ≥ 3 if female
Indication for treatment with an oral anticoagulant in
Written informed consent
Exclusion Criteria:
Ste-Foy, Quebec G1V 4G5, Canada
Miura-gun, Kanagawa 240-0116, Japan
Adachi-ku, Tokyo 123-0845, Japan
Koto-ku, Tokyo 136-0072, Japan