The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,000
One 15 mg tablet once daily for up to twelve months
One 75 mg tablet once daily for up to twelve months
One 90 mg tablet twice daily for up to twelve months
The composite endpoints of death and ischemic events
The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )
Time frame: one year
Clinically significant bleeding
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA)
Time frame: one year
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