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
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
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
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"
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
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
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
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
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
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
2 Canadian Journal of Cardiology 27 (2011) 389.e11-389.e18
3 Tracking Heart Disease and Stroke in Canada. Released June 2009.
4 Statistics Canada. Morality, Summary List of Causes 2008. Released
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
8 Conference Board of Canada. The Canadian Heart Health Strategy: Risk
Factors and Future Cost Implications. Report February 2010.
SOURCE Bayer Inc.