New Canadian-Led Global Study of Bayer's Xarelto® (rivaroxaban tablet), Initiated for the Secondary Prevention of

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 CAD(1). 
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, itsresearch 
interests are global and include a broad spectrum of health-related issues. 
Originally a cardiovascular disease research institute, PHRI's programs have 
expanded to includea broadrange ofmedical and societalconditions 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.

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

Ethan Pigott beSpeak Communications 416-558-2783 
ethan@bespeakcommunications.com

Marija Mandic Bayer Inc. 416-240-5376 Marija.Mandic@bayer.com

SOURCE: Bayer Inc.

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CO: Bayer Inc.
ST: Ontario
NI: MTC CHM HEA 

-0- Nov/13/2012 13:00 GMT


 
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