The phase three COMPASS trial, evaluating the efficacy and safety of rivaroxaban (Xarelto, Janssen) for the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or with peripheral artery disease, is stopping earlier than planned.
This decision is based on the recommendation of the study’s independent Data Monitoring Committee, as the primary major adverse cardiac events endpoint has reached its pre-specified criteria for superiority.
The estimated study completion date for the COMPASS trial had been March, 2018. 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, according to a press release.
The COMPASS trial evaluated rivaroxaban in patients with coronary artery disease or peripheral artery disease. It enrolled 27,402 patients from more than 600 sites across more than 30 countries worldwide. In the study, patients were randomised to receive either rivaroxaban 2.5mg twice daily in addition to aspirin 100mg once daily, rivaroxaban 5mg twice daily alone, or aspirin 100mg once daily alone.
A complete analysis of the data from the COMPASS trial is expected to be presented at a medical meeting in 2017.