KEY SECONDARY OUTCOME IN ALL-CAUSE MORTALITY1,2
COMPASS trial design: A phase 3, multicenter, double-dummy, event-driven study of patients with a stable atherosclerotic vascular disease. Using a 1:1:1 randomization, patients received XARELTO® 2.5 mg twice daily plus aspirin 100 mg once daily (n=9152), rivaroxaban 5 mg twice daily (n=9117), or aspirin 100 mg once daily (n=9126).
Because the rivaroxaban 5 mg dose alone was not superior to aspirin alone, only the data concerning the XARELTO® 2.5 mg dose plus aspirin are discussed.
COMPASS primary outcomes were a composite of cardiovascular death, stroke, and myocardial infarction. The principal safety outcome was a modification of the ISTH criteria for major bleeding and included fatal bleeding, symptomatic bleeding into a critical organ, bleeding into a surgical site requiring reoperation, and bleeding that led to hospitalization with or without an overnight stay.
*XARELTO® 2.5 mg twice daily plus aspirin 100 mg once daily.
†Not adjusted for multiplicity.
ARR = absolute risk reduction; BID = twice daily; ISTH = International Society on Thrombosis and Haemostasis; QD = once daily; RRR = relative risk reduction.