Landmark Phase III Study of Bayer's Xarelto® (Rivaroxaban) Initiated for the Secondary Prevention of Myocardial Infarcti

BERLIN, November 13, 2012 /PRNewswire/ --

Not intended for U.S. and UK Media

        
        - 20,000-patient study will be conducted in collaboration with Population
          Health Research Institute
        - Composite of cardiovascular death, myocardial infarction and stroke as primary
          efficacy endpoint
        - Rivaroxaban is the first novel oral anticoagulant under assessment in this
          high risk patient population

Bayer HealthCare announced today the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto(R) (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).

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/58642-COMPASS-Study

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 enroll 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 aging of the population.

About COMPASS

The Phase III study COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) will include approximately 20,000 patients from more than 450 sites across more than 25 countries worldwide. Patients with documented atherosclerosis related to CAD or PAD will be enrolled into the study. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction and stroke. The primary safety endpoint is major bleeding. In the study, patients will be 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. The study will be conducted by the Population Health Research Institute (PHRI), a leading academic health science research organization based in Hamilton, Ontario, Canada.

About the Population Health Research Institute (PHRI)

PHRI is a world-leading academic health science research institute focused on improving global health outcomes. Based in Hamilton, Ontario, Canada, its research interests are global and include a broad spectrum of health-related issues. Originally a cardiovascular disease research institute, PHRI's programmes have expanded to include a broad range of medical and societal conditions in varied populations defined by ethnicity and/or geographic region. To date, PHRI has conducted more than 50 global trials and epidemiological studies in more than 1,500 centres in 83 countries, involving over 500,000 patients. More information can be found at http://www.phri.ca

About Venous Arterial Thromboembolism (VAT) Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.

VAT is responsible for a number of serious and life threatening conditions:

        
        - Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep
          vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to
          the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary
          embolism (PE), an event which can be rapidly fatal
        - Arterial Thromboembolism occurs when oxygenated blood flow from the heart to
          another part of the body (via an artery) is interrupted by a blood clot. If this
          occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event
          that can be severely debilitating or fatal. If it occurs in a coronary artery, it can
          lead to acute coronary syndrome (ACS), a complication of coronary heart disease which
          includes conditions such as myocardial infarction (heart attack), and unstable angina

VAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.

To learn more about VAT, please visit http://www.VATspace.com

About Xarelto(R) (Rivaroxaban)

Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto(R). To date, Xarelto is approved for use in the following venous arterial thromboembolic (VAT) indications:

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