Phase 3 COMPASS study of Xarelto (rivaroxaban) stopping early for efficacy; study meets primary endpoint of prevention of major adverse cardiac events in patients with coronary artery disease or peripheral artery disease.
Janssen Research & Development, LLC announced that the Phase 3 COMPASS trial, evaluating the efficacy and safety of Xarelto (rivaroxaban) for the prevention of major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or with peripheral artery disease (PAD), is stopping earlier than planned.
The decision is based on the recommendation of the study’s independent Data Monitoring Committee (DMC), as the primary MACE endpoint has reached its pre-specified criteria for superiority.
The estimated study completion date for the COMPASS trial had been March, 2018i. Given the magnitude of effect, Janssen, Bayer and the Population Health Research Institute (PHRI), which collaborated on the COMPASS clinical trial, will offer rivaroxaban to study participants in an open-label extension trial.
The COMPASS trial evaluated Xarelto in patients with CAD or PAD. It enrolled 27,402 patients from more than 600 sites across more than 30 countries worldwide. In the study, patients were randomized to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone.
A complete analysis of the data from the COMPASS trial is expected to be presented at a medical meeting in 2017.
“Despite established and effective treatments, incidences of CAD and PAD are rising globally,” said Paul Burton, M.D., Ph.D., FACC, vice president, medical affairs, Janssen. “We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the U.S. Food and Drug Administration as quickly as possible.”
CAD affects 16.5 million Americansii. PAD affects more than 10 million Americansiii, and is a powerful risk marker of cardiovascular disease. Globally, screening studies suggest approximately 20 percent of adults older than 55 years have evidence of PADiv.
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References:
i https://clinicaltrials.gov/ct2/show/NCT01776424
ii Circulation. 2017; CIR.0000000000000485;ii AHA Statistical Update, Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association, Originally published January 25, 2017, page 360, downloaded from https://circ.ahajournals.org/content/early/2017/01/25/CIR.0000000000000485
iii Circulation. 2017;CIR.0000000000000485; AHA Statistical Update, Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association, Originally published January 25, 2017, page 408, downloaded from https://circ.ahajournals.org/content/early/2017/01/25/CIR.0000000000000485
(Source: PR Newswire)
Filed Under: Drug Discovery
