Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease - Full Text View

Purpose

The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.

Condition	Intervention	Phase
Prevention & Control	Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin Drug: Aspirin placebo Drug: Rivaroxaban placebo Drug: Pantoprazole	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS)

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Heart Attack Peripheral Arterial Disease

Drug Information available for: Aspirin Pantoprazole Rivaroxaban

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, revascularization, venous thromboembolism or cardiovascular hospitalization [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]


Estimated Enrollment:	21400
Study Start Date:	February 2013
Estimated Study Completion Date:	February 2018
Estimated Primary Completion Date:	January 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rivaroxaban [2.5mg] + Aspirin Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily	Drug: Rivaroxaban (Xarelto, BAY59-7939) Rivaroxaban 2.5 mg twice daily, tablet Drug: Aspirin Aspirin 100 mg once daily, tablet Drug: Pantoprazole Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
Experimental: Rivaroxaban [5mg] + Placebo(1) Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily	Drug: Rivaroxaban (Xarelto, BAY59-7939) Rivaroxaban 5.0 mg twice daily, tablet Drug: Aspirin placebo Placebo(1), matching Aspirin tablets Drug: Pantoprazole Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
Active Comparator: Aspirin + Placebo(2) Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily	Drug: Aspirin Aspirin 100 mg once daily, tablet Drug: Rivaroxaban placebo Placebo(2), matching Rivaroxaban tablets Drug: Pantoprazole Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

-- Coronary or peripheral artery disease

Patients with coronary artery disease must also meet at least one of the following:

Age ≥65, or
Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors

Exclusion Criteria:

Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
Stroke within 1 month or any history of hemorrhagic or lacunar stroke
Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms
Estimated glomerular filtration rate (eGFR)<15 mL/min

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776424

Contacts


Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 366 Study Locations

Sponsors and Collaborators

Bayer

Hamilton Health Sciences Corporation, Population Health Research Institute

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01776424 History of Changes
Other Study ID Numbers:	15786, 2012-004180-43
Study First Received:	January 24, 2013
Last Updated:	February 5, 2015
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Brazil: National Health Surveillance Agency Canada: Health Canada Chile: Instituto de Salud Pública de Chile China: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Denmark: Danish Health and Medicines Authority Ecuador: Public Health Ministry Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: Scientific and Medical Research Council Ethics Committee Ireland: Irish Medicines Board Israel: Ministry of Health Italy: The Italian Medicines Agency Japan: Pharmaceuticals and Medical Devices Agency Malaysia: National Pharmaceutical Control Bureau Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Philippines : Food and Drug Administration Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Slovakia: The Ministry of Health of the Slovak Republic South Africa: Department of Health South Korea: Korea Food and Drug Administration (KFDA) Sweden: Medical Products Agency Switzerland: Swissmedic Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Romania: National Agency for Medicines and Medical Devices

Keywords provided by Bayer:


Cardiovascular events Rivaroxaban Xarelto anticoagulant blood thinner aspirin ASA CAD coronary disease	artery disease coronary artery bypass graft stroke heart attack angina arterial vascular disease transient ischemic attack TIA heart disease

Additional relevant MeSH terms:


Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases Aspirin Rivaroxaban Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Anticoagulants Antipyretics	Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)