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Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00007657
Collaborator
Medical Research Council of Canada (Other), Merck Sharp & Dohme LLC (Industry), Pfizer (Industry), GE Healthcare (Industry), Bristol-Myers Squibb (Industry), Astellas Pharma Inc (Industry), AstraZeneca (Industry), Sanofi (Industry), Datascope Corp. (Industry), First Horizon (Other), Kos (Other), Key Pharmaceuticals (Industry), Integrated Therapeutics Group (Industry), Hoest-Marion-Roussel (Other)
3,260
Enrollment
48
Locations
2
Arms
90
Duration (Months)
67.9
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intensive medical therapy
  • Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3260 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation
Study Start Date :
Dec 1, 1998
Actual Study Completion Date :
Jun 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    2 Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock No. Little Rock Arkansas United States 72114-1706
    3 Southern CA Kaiser Permanente Medical Group Los Angeles California United States 90027
    4 VA Northern California HCS Sacramento California United States 95655
    5 Hartford Hospital Hartford Connecticut United States 06102-5037
    6 Christiana Care Health Systems-Newark, DE Newark Delaware United States 19718
    7 MIMA Century Research Associates - Melbourne, FL Melbourne Florida United States 32901
    8 James A. Haley Veterans Hospital, Tampa Tampa Florida United States 33612
    9 Atlanta VA Medical and Rehab Center, Decatur Decatur Georgia United States 30033
    10 Jesse Brown VAMC (WestSide Division) Chicago Illinois United States 60612
    11 Genesis Medical Center Davenport Iowa United States 52803-2498
    12 VA Medical Center, Iowa City Iowa City Iowa United States 52246-2208
    13 VA Medical Center, Lexington Lexington Kentucky United States 40502
    14 VA Maryland Health Care System, Baltimore Baltimore Maryland United States 21201
    15 VA Medical Center, Jamaica Plain Campus Boston Massachusetts United States 02130
    16 VA Ann Arbor Healthcare System Ann Arbor Michigan United States 48113
    17 John D. Dingell VA Medical Center, Detroit Detroit Michigan United States 48201
    18 Mayo Clinic Rochester - Rochester, MN Rochester Minnesota United States 55905
    19 VA Medical Center, Kansas City MO Kansas City Missouri United States 64128
    20 VA Medical Center, St Louis St Louis Missouri United States 63106
    21 New Mexico VA Health Care System, Albuquerque Albuquerque New Mexico United States 87108-5153
    22 New York Harbor HCS New York New York United States 10010
    23 University of Rochester Strong Memorial Hospital Rochester New York United States 14642-8679
    24 VA Medical Center, Syracuse Syracuse New York United States 13210
    25 VA Medical Center, Durham Durham North Carolina United States 27705
    26 VA Medical Center, Cleveland Cleveland Ohio United States 44106
    27 VA Medical Center, Oklahoma City Oklahoma City Oklahoma United States 73104
    28 VA Medical Center, Portland Portland Oregon United States 97201
    29 VA Medical Center, Philadelphia Philadelphia Pennsylvania United States 19104
    30 VA Medical Center, Memphis Memphis Tennessee United States 38104
    31 VA Medical Center Nashville Tennessee United States 37212-2637
    32 Michael E. DeBakey VA Medical Center (152) Houston Texas United States 77030
    33 VA South Texas Health Care System, San Antonio San Antonio Texas United States 78229
    34 VA Puget Sound Health Care System, Seattle Seattle Washington United States 98108
    35 Foothills Hospital - Calgary, Alberta - Can Calgary Alberta Canada T2N 2T9
    36 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    37 St Paul's Hospital, Vancouver - British Columbia Vancouver British Columbia Canada V6Z 1Y6
    38 St. John Regional Hospital Facility St. John New Brunswick Canada E2L 4L2
    39 Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can Halifax Nova Scotia Canada B3H 3A7
    40 Hamilton General Hospital - Hamilton, Ont - Can Hamilton Ontario Canada L8L 2X2
    41 London Health Sciences Ctr - London, Ont - Can London Ontario Canada N6A 5A5
    42 Trillium Health Care Mississauga Ontario Canada L5B 2P7
    43 Sudbury Regional Hospital - Sudbury, Ontario Sudbury Ontario Canada P3E 2N8
    44 Sunnybrook HSC - Toronto, Ontario Toronto Ontario Canada M4N 3M5
    45 St. Michael'S Hospital, Toronto, Ontario - Can Toronto Ontario Canada M5B 1W8
    46 University Health Network Toronto Ontario Canada M5G 2C4
    47 Montreal Heart Institute - Montreal, Quebec - Can Montreal Quebec Canada H1T 1C8
    48 Hopital du Sacre-Coeur de Montreal Montreal Quebec Canada H4J1C5

    Sponsors and Collaborators

    • US Department of Veterans Affairs
    • Medical Research Council of Canada
    • Merck Sharp & Dohme LLC
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00007657
    Other Study ID Numbers:
    • 424
    First Posted:
    Jan 4, 2001
    Last Update Posted:
    Jun 15, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    PCI plus intensive medical therapy
    Additional relevant MeSH terms:
    Myocardial Ischemia
    Ischemia

    Study Results

    No Results Posted as of Jun 15, 2009