New Canadian-Led Global Study of Bayer's Xarelto® (rivaroxaban tablet), Initiated for the Secondary Prevention of Cardiovascular Death, Myocardial Infarction and Stroke in Patients with Coronary or Peripheral Artery Disease

• Coronary or Peripheral Artery Disease patients carry significant risk of fatal or debilitating myocardial infarction and stroke
• Rivaroxaban is the first novel oral anticoagulant currently under investigation in this high risk patient population
• 20,000-patient study will be conducted in collaboration with Canada's Population Health Research Institute (PHRI), representing one of the largest clinical trial investments in cardiovascular medicine in Canada

TORONTO, Nov. 13, 2012 /CNW/ - Bayer Inc. and the Population Health Research Institute (PHRI), a joint Institute of Hamilton Health Sciences Corporation and McMaster University, announced today the initiation of the COMPASS trial, the largest clinical study of the oral anticoagulant rivaroxaban to-date. COMPASS is a Phase III trial that will investigate 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 COMPASS study will assess the potential of rivaroxaban to provide additional prevention of cardiovascular events to patients when added to an antiplatelet therapy, as well as investigating rivaroxaban and an antiplatelet as single treatments. The study will be conducted in collaboration with the PHRI and will enroll approximately 20,000 patients from more than 450 sites across more than 25 countries.  In Canada, the study will enroll approximately 2,250 patients from more than 45 sites and will represent a significant investment in Canadian-led research over the next several years.

"Although there are therapies that offer significant protection for patients with coronary or peripheral artery disease, a significant risk of heart attacks, 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 investigate additional, potentially complementary, cardioprotective benefits 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 (CAD) or the legs (PAD). 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.

"The COMPASS trial represents a significant investment in Canadian clinical research and a global recognition of Canadian science," said Dr. Shurjeel Choudhri, Senior Vice President and Head, Medical and Scientific Affairs Bayer Inc. "The clinical research expertise of Dr. Yusuf and the PHRI team speaks to the strong talent that exists in Canada. Bayer is proud to be collaborating with the PHRI on such a major study that has the potential to offer new insight into the prevention of major adverse cardiac events for the millions of patients worldwide living with coronary artery disease or peripheral artery disease."

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. In 2009, approximately 36,000 Canadians died from CAD¹. 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" worldwide.

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. In Canada, more than 800,000 people are affected by the disease.² Globally, screening studies suggest that approximately 20 per cent 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 Heart Disease in Canada
In 2007, 1.3 million Canadians reported having heart disease. ³   It is one of the three leading causes of death in Canada.⁴  Ninety per cent of Canadians have at least one risk factor for heart disease or stroke (smoking, alcohol, physical inactivity, obesity, high blood pressure, high blood cholesterol, diabetes).⁵ In Canada, someone dies from heart disease and stroke every seven minutes.⁶

In 2009, heart disease accounted for 28.6 per cent of all deaths in Canada (68,342 deaths).⁷  Heart disease and stroke costs the Canadian economy more than $20.9 billion every year in physician services, hospital costs, lost wages and decreased productivity.⁸

About COMPASS
COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) will include approximately 20,000 patients from more than 450 sites across more than 25 countries. 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 investigational doses of either: rivaroxaban 2.5mg twice-daily in addition to an antiplatelet; rivaroxaban 5mg twice-daily alone; or an antiplatelet alone. Patients will also be randomized to receive a proton pump inhibitor. The study will investigate whether such an approach would lead to a reduction in cardiac events and bleeding. The study will be conducted by the Population Health Research Institute (PHRI).

About the Population Health Research Institute (PHRI)
PHRI is a leading academic health science research institute focused on improving global health outcomes. Based in Hamilton, ON, its research interests are global and include a broad spectrum of health-related issues. Originally a cardiovascular disease research institute, PHRI's programs 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 80 major trials and epidemiological studies in more than 1,500 centres in 83 countries, involving over one million individuals. More information can be found at www.phri.ca.

About Xarelto^® (rivaroxaban tablet)
Xarelto^® (rivaroxaban tablet) is indicated for the prevention of stroke and systemic embolism in patients with AF, in whom anticoagulation is appropriate, as well as for the treatment of deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE), and for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery. To date, rivaroxaban is approved in more than 120 countries worldwide for the prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery. Market authorization has not been obtained for the prevention of major adverse cardiac events (MACE) in patients with coronary artery disease (CAD) or peripheral artery disease (PAD), which is currently the subject of the Phase III COMPASS trial.

The extensive clinical trial program investigating rivaroxaban makes it one of the most studied and widely published oral, direct Factor-Xa inhibitors. The studies, reported and ongoing, involve over 75,000 patients for the prevention and treatment of venous and arterial thromboembolic disorders across a broad range of acute and chronic conditions, including those for which market authorization has not yet been obtained, such as the secondary prevention of acute coronary syndrome and treatment of pulmonary embolism.

Xarelto^® (rivaroxaban tablet) like other anticoagulants, should be used with caution in patients with an increased risk of bleeding. Bleeding can occur at any site during therapy with rivaroxaban. The possibility of a hemorrhage should be considered in evaluating the condition of any anticoagulated patient. Any unexplained fall in hemoglobin or blood pressure should lead to a search for a bleeding site.

Patients at high risk of bleeding should not be prescribed rivaroxaban. Should severe bleeding occur, treatment with rivaroxaban must be discontinued and the source of bleeding investigated promptly. The use of rivaroxaban is not recommended in patients with severe renal impairment.

Physicians should refer to the Xarelto^® (rivaroxaban tablet) Product Monograph for complete information.

*Xarelto^® (rivaroxaban tablet) 15 mg and 20 mg tablets should be taken with food.

About Bayer Inc. 
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.

Bayer Inc. has approximately 800 employees across Canada and had sales of $808 million CDN in 2011. Globally, the Bayer Group had sales of over 36 billion Euro in 2011. Bayer Inc. invested approximately $13 million CDN in research and development in 2011. Worldwide, the Bayer Group spent the equivalent of over 2.9 billion Euro in 2011 in R&D. For more information, go to www.bayer.ca.

¹ Statistics Canada. Morality, Summary List of Causes 2009. Released July, 2012.
² Canadian Journal of Cardiology 27 (2011) 389.e11-389.e18 www.onlinecjc.ca
³ Tracking Heart Disease and Stroke in Canada. Released June 2009.
⁴ Statistics Canada. Morality, Summary List of Causes 2008. Released October, 2011.
⁵ Heart and Stroke Foundation - www.heartandstroke.com
⁶ Heart and Stroke Foundation - www.heartandstroke.com
⁷ Statistics Canada. Morality, Summary List of Causes 2009. Released July, 2012.
⁸ Conference Board of Canada. The Canadian Heart Health Strategy: Risk Factors and Future Cost Implications. Report February 2010.

SOURCE: Bayer Inc.

For more information, or to arrange an interview, contact:

Ethan Pigott
beSpeak Communications
416-558-2783
[email protected]

Marija Mandic
Bayer Inc.
416-240-5376
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