Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

NCT ID: NCT00007657

Last Updated: 2009-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-12-31
• Study Completion Date: 2006-06-30

Brief Summary

PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI.

Detailed Description

Primary Hypothesis: The strategy of PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI in patients with documented myocardial ischemia who meet an AHA task force Class I indication for PCI.

Secondary Hypotheses: Resource utilization and QOL comparisons and hospitalization for acute coronary syndromes will be superior in PCI plus medical therapy compared to medical therapy alone.

Primary Outcomes: All cause mortality, nonfatal MI.

Interventions: All patients will be treated with intensive medical therapy. In addition half of them will receive percutaneous coronary intervention (PCI).

Study Abstract: The COURAGE Trial is a large-scale, multicenter, randomized controlled trial comparing medical therapy and PCI plus medical therapy that is powered for "hard" clinical endpoints. Patients eligible for inclusion in COURAGE will comprise all but very high-risk subjects, and will include those with chronic angina pectoris (Canadian Cardiovascular Society [CCS] Class I-III), recent uncomplicated MI, and asymptomatic (or "silent") myocardial ischemia. Patients may have single- or multi-vessel coronary artery disease and may have had prior bypass graft surgery or PCI. We project cumulative 3-year event rates of 16.4% and 21%, respectively, which yields an absolute difference of 4.6% or relative difference of 22%. With a minimum duration of follow-up of 2 1/2 years, a maximum of 7 years, using a two-sided test of significance at the 0.05 level, and assuming a 3% crossover rate then 2% then 1% each for 2 years from meds to PCI, and annual loss to follow-up rate of 1% these event rates indicate that a sample size of 2,270 will be needed to test the hypothesis with 85% power. Fifteen VA, 19 U.S. non-VA, and 16 Canadian sites enrolled in the study. The planned study duration was 7 years, with 4 1/2 years of patient intake and 2 1/2 - 7 years of follow-up. Study operations began in January 1999 and enrollment began in June 1999. The Data and Safety Monitoring Board approved reducing the sample size to 2,270 subjects based on increasing the length of randomization and follow-up and updating the definition of MI to include biomarker positive (troponin) ACS. Enrollment is complete with 2,287 patients enrolled.

Conditions

Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

1

Percutaneous Coronary Intervention (PCI) plus intensive medical therapy

Group Type: EXPERIMENTAL

Intensive medical therapy

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention (PCI) plus intensive medical therapy

Intervention Type: PROCEDURE

2

Intensive medical therapy

Group Type: ACTIVE_COMPARATOR

Intensive medical therapy

Intervention Type: PROCEDURE

Interventions

Intensive medical therapy

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention (PCI) plus intensive medical therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients eligible for inclusion in COURAGE will comprise all but very high-risk subjects, and will include those with chronic angina pectoris (Canadian Cardiovascular Society [CCS] Class I-III), uncomplicated MI, cooled down ACS, and asymptomatic (or "silent") myocardial ischemia.
• Patients may have single- or multi-vessel coronary artery disease and may have had prior bypass graft surgery or PCI.

It is important to emphasize that as many types of CAD patients as possible--reflecting the spectrum of patients encountered in contemporary clinical practice--will be enrolled in COURAGE.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council of Canada

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Datascope Corp.

INDUSTRY

Sponsor Role: collaborator

First Horizon

UNKNOWN

Sponsor Role: collaborator

Kos

UNKNOWN

Sponsor Role: collaborator

Key Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Integrated Therapeutics Group

INDUSTRY

Sponsor Role: collaborator

Hoest-Marion-Roussel

UNKNOWN

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Department of Veterans Affairs

Principal Investigators

William E. Boden

Role: STUDY_CHAIR

VA South Texas Health Care System, San Antonio

Locations

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, United States

Southern CA Kaiser Permanente Medical Group

Los Angeles, California, United States

VA Northern California HCS

Sacramento, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Christiana Care Health Systems-Newark, DE

Newark, Delaware, United States

MIMA Century Research Associates - Melbourne, FL

Melbourne, Florida, United States

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, United States

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, United States

Jesse Brown VAMC (WestSide Division)

Chicago, Illinois, United States

Genesis Medical Center

Davenport, Iowa, United States

VA Medical Center, Iowa City

Iowa City, Iowa, United States

VA Medical Center, Lexington

Lexington, Kentucky, United States

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, United States

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, United States

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, United States

Mayo Clinic Rochester - Rochester, MN

Rochester, Minnesota, United States

VA Medical Center, Kansas City MO

Kansas City, Missouri, United States

VA Medical Center, St Louis

St Louis, Missouri, United States

New Mexico VA Health Care System, Albuquerque

Albuquerque, New Mexico, United States

New York Harbor HCS

New York, New York, United States

University of Rochester Strong Memorial Hospital

Rochester, New York, United States

VA Medical Center, Syracuse

Syracuse, New York, United States

VA Medical Center, Durham

Durham, North Carolina, United States

VA Medical Center, Cleveland

Cleveland, Ohio, United States

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, United States

VA Medical Center, Portland

Portland, Oregon, United States

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, United States

VA Medical Center, Memphis

Memphis, Tennessee, United States

VA Medical Center

Nashville, Tennessee, United States

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, United States

VA South Texas Health Care System, San Antonio

San Antonio, Texas, United States

VA Puget Sound Health Care System, Seattle

Seattle, Washington, United States

Foothills Hospital - Calgary, Alberta - Can

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

St Paul's Hospital, Vancouver - British Columbia

Vancouver, British Columbia, Canada

St. John Regional Hospital Facility

Saint John, New Brunswick, Canada

Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can

Halifax, Nova Scotia, Canada

Sudbury Regional Hospital - Sudbury, Ontario

Greater Sudbury, Ontario, Canada

Hamilton General Hospital - Hamilton, Ont - Can

Hamilton, Ontario, Canada

London Health Sciences Ctr - London, Ont - Can

London, Ontario, Canada

Trillium Health Care

Mississauga, Ontario, Canada

Sunnybrook HSC - Toronto, Ontario

Toronto, Ontario, Canada

St. Michael'S Hospital, Toronto, Ontario - Can

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Montreal Heart Institute - Montreal, Quebec - Can

Montreal, Quebec, Canada

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Countries

United States; Canada

References

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Other Identifiers

424

Identifier Type: -

Identifier Source: org_study_id