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Published on 13 November 2012

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Landmark Phase III Study of Bayer’s Xarelto®

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Bayer HealthCare has announced the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto® (rivaroxaban) to date, investigating 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).
The Phase III study COMPASS will assess the potential of rivaroxaban to provide important additional protection to patients when added to aspirin as compared to rivaroxaban and aspirin as single treatments. The study will be conducted in collaboration with the Population Health Research Institute (PHRI) and will enrol approximately 20,000 patients from more than 450 sites across more than 25 countries worldwide.
“Today, aspirin is the gold standard and provides significant protection for patients with coronary or peripheral artery disease. However, a residual risk of cardiac events such as heart attack, stroke or even death remains in these high-risk patients,” said Dr. Salim Yusuf, Executive Director of the PHRI, Canada, and Principal Investigator of the COMPASS study. “This is therefore an important study, designed to provide significant insights on additional, potentially complementary, cardioprotective benefits of rivaroxaban for these patients.”
In CAD and PAD, the inner wall of the arteries progressively thickens due to accumulation of lipids, calcification and cell proliferation. This plaque narrows the arteries and decreases the amount of blood flow to the heart muscle or the legs. This process is called atherosclerosis. If plaque from the wall of an artery ruptures, a blood clot can form at the site of the rupture leading to serious events including myocardial infarction, stroke or even death.
Currently, the most commonly prescribed treatments for the prevention of MACE in CAD and PAD patients are antiplatelet agents such as aspirin – a product with a well documented role in the prevention of cardiovascular events across a broad range of patients.
“Antiplatelet therapies and rivaroxaban have complementary mechanisms of action and when combined have been shown to improve outcomes in patients with acute coronary syndrome. In the same way, COMPASS will evaluate whether the combination has the potential for more complete protection against long-term clot formation in patients with CAD and PAD in comparison to each of the products alone,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
About the burden of coronary and peripheral artery disease
Coronary artery disease (CAD) 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 (PAD), while often undiagnosed, affects over 27 million people in Europe and North America and is a powerful 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 ageing of the population.


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