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The phase III trial COMPASS evaluating the efficacy and safety of Rivaroxaban ( Xarelto ) for the prevention of major adverse cardiac events ( MACE ) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease ( CAD ) or peripheral artery disease ( PAD ) has met its primary endpoint ahead of time.
Following a planned interim analysis conducted by the independent Data Monitoring Committee ( DMC ), the DMC recommended to stop the trial early as the primary MACE endpoint has reached its prespecified criteria for superiority.
Owing to the magnitude of effect and the confirmation of the existing safety profile of Rivaroxaban, Population Health Research Institute ( PHRI ) will offer Rivaroxaban to study participants in an open-label extension trial.
The COMPASS study is the largest clinical study of Rivaroxaban to date.

The phase III COMPASS study has 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 Acetylsalicylic acid ( Aspirin ) 100 mg once daily, Rivaroxaban 5 mg twice daily alone, or Aspirin 100 mg once daily alone.

Coronary artery disease is the most common cause of cardiovascular disease and is responsible for approximately 7.3 million deaths worldwide every year. One-third to one-half of all middle-aged men and women in high income countries are at risk of developing CAD during their lifetime, and the number of people with CAD is rising globally.
By 2020, the burden of coronary artery disease is projected to reach 82 million disability-adjusted life years ( DALYs ) or healthy years of life lost.

Peripheral artery disease, while often undiagnosed, affects over 27 million people in Europe and North America and is an important risk marker of cardiovascular disease. Globally, screening studies suggest that approximately 20% of adults older than 55 years have evidence of PAD. The disease prevalence is strongly age-related and, like CAD, the numbers of affected patients is rising, because of the aging of the population.

COMPASS is part of the extensive investigation of Rivaroxaban, which, by the time of its completion, is expected to include more than 275,000 patients in both clinical trials and real-world settings.

Rivaroxaban, a non-vitamin K antagonist oral anticoagulant ( NOAC ), is approved for seven indications: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors; treatment of pulmonary embolism in adults; treatment of deep vein thrombosis in adults; prevention of recurrent deep vein thrombosis and pulmonary embolism in adults; prevention of venous thromboembolism in adult patients undergoing elective hip replacement surgery; prevention of venous thromboembolism in adult patients undergoing elective knee replacement surgery; prevention of atherothrombotic events ( cardiovascular death, myocardial infarction or stroke ) after an acute coronary syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack ( TIA ) when co-administered with Acetylsalicylic acid ( ASA ) alone or with ASA plus Clopidogrel or Ticlopidine, ( Xagena )

Source: Bayer, 2017

XagenaMedicine2017