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FDA, EMA and Health Canada Indications Based on COMPASS

The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada have new indications for the prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality, in patients with coronary artery disease or peripheral artery disease. The indications are based on evidence from PHRI’s COMPASS study [Cardiovascular Outcomes for People Using Anticoagulation Strategies].

More than 27,000 participants were enrolled in 33 countries as part of COMPASS, which demonstrated that rivaroxaban (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.

“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. “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.”

COMPASS was conducted by PHRI in collaboration with Bayer Inc.

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

L to R: Drs. John Eikelboom, Sonia Anand, Stuart Connolly, co-PIs, COMPASS.