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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
Berlin, Germany, November 13, 2012 - Bayer HealthCare announced today 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
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 A
nticoagulation 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 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 www.VATspace.com
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated new oral anticoagulant and is
marketed under the brand name Xarelto®. To date, Xarelto is approved for use in
the following venous arterial thromboembolic (VAT) indications:
The prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation (AF) with one or more risk factors in more
than 70 countries worldwide
The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and
pulmonary embolism (PE) in adults in more than 70 countries worldwide
In the U.S. also for the treatment of pulmonary embolism and prevention of
recurrent PE and DVT in adults
The prevention of venous thromboembolism (VTE) in adult patients undergoing
elective hip or knee replacement surgery in more than 120 countries worldwide
Since the first approval of Xarelto in 2008, more than two and a half million
patients worldwide have now received Xarelto in daily clinical practice.
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed
with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S.
by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson
& Johnson Company).
Anticoagulant medicines are potent therapies used to prevent or treat serious
illnesses and potentially life threatening conditions. Before initiating
therapy with anticoagulant medicines, physicians should carefully assess the
benefit and risk for the individual patient.
Responsible use of Xarelto is a high priority for Bayer, and the company has
developed a Prescribers Guide for physicians and a Xarelto Patient Card for
patients to support best practices.
To learn more, please visit: https://prescribe.xarelto.com
To learn more about thrombosis, please visit www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.com
About Aspirin®
Acetylsalicylic acid, the active ingredient in Aspirin®, has been extensively
investigated in more than 200 studies involving more than 200,000 patients
across varying levels of cardiovascular (CV) risk. Given the existing body of
clinical evidence, low-dose aspirin use in appropriate patients is approved by
regulatory authorities around the world for CV event prevention, and supported
by major evidence-based clinical guidelines, including those of the American
Heart Association and American College of Cardiology, European Society of
Cardiology, and American College of Chest Physicians.
Based on its proven efficacy, safety and cost-effectiveness, low-dose aspirin
continues to be the standard of care for reducing heart attacks and ischemic
strokes in patients with established CV disease. Additionally, in more than 50
countries around the world, low-dose aspirin is approved for use in the primary
prevention of CV events in appropriate at risk patients. When used as directed
by a physician, low-dose aspirin is infrequently associated with clinically
significant side effects. Serious bleeding rarely occurs. Gastro-intestinal
bleeding (GI) has been shown to occur in less than 1% of those taking aspirin
to prevent a recurrent CV event; serious GI or extracranial bleeding events are
expected in less than 1/10th of one percent (3 in 10,000 people per year)
patients taking low-dose aspirin for primary prevention (1). Bayer supports the
use of aspirin for primary prevention only in those markets where the
indications have been approved.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup
of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world's
leading, innovative companies in the healthcare and medical products industry
and is based in Leverkusen, Germany. The company combines the global activities
of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare's aim is to discover, develop, manufacture and
market products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is
represented in more than 100 countries. More information at
www.healthcare.bayer.com.
Our online press service is just a click away: press.healthcare.bayer.com
Information for editors:
For full multimedia release, including additional material such as videos and
backgrounders, please visit http://www.multivu.com/mnr/58642-COMPASS-Study
Find more information at www.bayerpharma.com.
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(1) Antithrombotic Trialists' (ATT) Collaboration. Aspirin in the primary
and secondary prevention of vascular disease: collaborative meta-analysis of
individual participant data from randomised clinical trials. The Lancet 2009;
373:1849-1860
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