XARELTO® VASCULAR DOSE*: COMPASS CLINICAL TRIAL IN PATIENTS WITH CAD AND/OR PAD1-3

Supported by robust evidence in ~27,395 patients1,2

Trial Design

TRIAL DESIGN1

The COMPASS trial was a phase 3, multicenter, double-dummy, event-driven study of patients with a history of 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.

ACE = angiotensin-converting enzyme; ARB = angiotensin II receptor blocker; CABG = coronary artery bypass graft; CAD = coronary artery disease; CV = cardiovascular; CYP3A = cytochrome P450; eGFR = estimated glomerular filtration rate; ISTH = International Society on Thrombosis and Haemostasis; MI = myocardial infarction; NSAID = nonsteroidal anti-inflammatory drug; NYHA = New York Heart Association; PAD = peripheral artery disease; PPI = proton pump inhibitor.

*XARELTO® 2.5 mg twice daily plus aspirin 100 mg once daily.
Post-CABG patients were not included in the 30-day run-in.