Endpoints
bleeding, death, cardiovascular death, Thrombosis, cardiac arrest, Cardiovascular deaths, thromboembolism
BLEEDING, MYOCARDIAL INFARCTION, MYOCARDIAL INFARCTION, STROKE, AORTIC DISSECTION, SUDDEN DEATH, THROMBOSIS, CARDIAC ARREST, ISCHEMIC STROKE, THROMBOEMBOLISM, HEART FAILURE
The primary efficacy endpoint of the OPTIMA‐4 trial is a composite of cardiovascular death, myocardial infarction, unplanned revascularization, ischemic stroke, and systematic thromboembolism during 12‐month follow‐up. The primary safety endpoint is major bleeding and clinically relevant nonmajor bleeding (CRNMB) defined by the International Society of Thrombosis and Hemostasis (ISTH) during 12‐month follow‐up.Cardiovascular deaths include death from myocardial infarction, stroke, heart failure, aortic dissection, cardiac arrest (sudden death), cardiovascular operations, and unknown causes for which investigators fail to acquire any relevant information in the follow‐up.