Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council of Canada
Merck Sharp & Dohme Corp.
Pfizer
GE Healthcare
Bristol-Myers Squibb
Astellas Pharma Inc
AstraZeneca
Sanofi
Datascope Corp.
First Horizon
Kos
Key Pharmaceuticals
Integrated Therapeutics Group
Hoest-Marion-Roussel
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007657
First received: December 29, 2000
Last updated: June 12, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Ischemia
Procedure: Intensive medical therapy
Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 3260
Study Start Date: December 1998
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: 1
Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Procedure: Intensive medical therapy Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Active Comparator: 2
Intensive medical therapy
Procedure: Intensive medical therapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  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: NCT00007657

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
Southern CA Kaiser Permanente Medical Group
Los Angeles, California, United States, 90027
VA Northern California HCS
Sacramento, California, United States, 95655
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Delaware
Christiana Care Health Systems-Newark, DE
Newark, Delaware, United States, 19718
United States, Florida
MIMA Century Research Associates - Melbourne, FL
Melbourne, Florida, United States, 32901
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
United States, Illinois
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States, 60612
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803-2498
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
United States, Kentucky
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Rochester - Rochester, MN
Rochester, Minnesota, United States, 55905
United States, Missouri
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States, 64128
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
New York Harbor HCS
New York, New York, United States, 10010
University of Rochester Strong Memorial Hospital
Rochester, New York, United States, 14642-8679
VA Medical Center, Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Oklahoma
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Canada, Alberta
Foothills Hospital - Calgary, Alberta - Can
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
St Paul's Hospital, Vancouver - British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, New Brunswick
St. John Regional Hospital Facility
St. John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton General Hospital - Hamilton, Ont - Can
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Ctr - London, Ont - Can
London, Ontario, Canada, N6A 5A5
Trillium Health Care
Mississauga, Ontario, Canada, L5B 2P7
Sudbury Regional Hospital - Sudbury, Ontario
Sudbury, Ontario, Canada, P3E 2N8
St. Michael'S Hospital, Toronto, Ontario - Can
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook HSC - Toronto, Ontario
Toronto, Ontario, Canada, M4N 3M5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal Heart Institute - Montreal, Quebec - Can
Montreal, Quebec, Canada, H1T 1C8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5
Sponsors and Collaborators
Medical Research Council of Canada
Merck Sharp & Dohme Corp.
Pfizer
GE Healthcare
Bristol-Myers Squibb
Astellas Pharma Inc
AstraZeneca
Sanofi
Datascope Corp.
First Horizon
Kos
Key Pharmaceuticals
Integrated Therapeutics Group
Hoest-Marion-Roussel
Investigators
Study Chair: William E. Boden VA South Texas Health Care System, San Antonio
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boden, William - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007657     History of Changes
Other Study ID Numbers: 424
Study First Received: December 29, 2000
Last Updated: June 12, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PCI plus intensive medical therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014