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

Landmark Phase III Study of Bayer's Xarelto® (Rivaroxaban) Initiated for the 
Secondary Prevention of Myocardial Infarction and Death in Patients with 
Coronary or Peripheral Artery Disease 

    --  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, Nov. 13, 2012 /CNW/ - 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).

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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 

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 

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.


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, 
itsresearch interests are global and include a broad spectrum of 
health-related issues. Originally a cardiovascular disease research institute, 
PHRI's programmes 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 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

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 

To learn more about VAT, please visit

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 Xareltoin 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:

To learn more about thrombosis, please visit

To learn more about Xarelto, please visit

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

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Forward-Looking Statements

This release may contain forward-looking statements based on current 
assumptions and forecasts made by Bayer Group or subgroup management. Various 
known and unknown risks, uncertainties and other factors could lead to 
material differences between the actual future results, financial situation, 
development or performance of the company and the estimates given here. These 
factors include those discussed in Bayer's public reports which are available 
on the Bayer website at The company assumes no liability 
whatsoever to update these forward-looking statements or to conform them to 
future events or developments.

  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


Astrid Kranz, Tel. +49-30-468-12057,; 
Stephanie Prate, Tel. +49-30-468-196053,

SOURCE: Bayer HealthCare

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CO: Bayer HealthCare

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