Health Canada Indication Based on COMPASS

Health Canada has approved XARELTO® (rivaroxaban) in combination with ASA for prevention of stroke, myocardial infarction and cardiovascular death, and prevention of acute limb ischemia and mortality in patients with CAD or PAD. The indication is based on evidence from the COMPASS study, which enrolled 27,395 patients from more than 30 countries, including 50 trial sites in Canada. COMPASS was conducted by PHRI in collaboration with Bayer Inc.

“It’s like giving these patients an additional seat belt against future heart attacks and stroke,” said Dr. John Eikelboom, co-principal investigator for COMPASS, and Associate Professor, Division of Hematology and Thromboembolism, Department of Medicine, McMaster University.

The COMPASS results, which support the new indication, have shown that combining ASA with the anticoagulant Xarelto is far more effective than ASA alone, and should change the way clinicians treat these high-risk patients,” Dr. Eikelboom added.

The COMPASS study demonstrated that XARELTO® 2.5 mg twice daily in combination with acetylsalicylic acid (ASA) 75 mg – 100 mg once daily reduced the risk of the composite outcome of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared to ASA 100 mg once daily alone.

L to R: Drs. John Eikelboom, Sonia Anand, Stuart Connolly, PHRI

L to R: Drs. John Eikelboom, Sonia Anand, Stuart Connolly, PHRI