Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

June 12, 2009 updated by: US Department of Veterans Affairs

CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Bristol-Myers Squibb
Sanofi
GE Healthcare
Merck Sharp & Dohme LLC
Pfizer
AstraZeneca
Astellas Pharma Inc
Integrated Therapeutics Group
Datascope Corp.
Medical Research Council of Canada
First Horizon
Kos
Key Pharmaceuticals
Hoest-Marion-Roussel

Investigators

  • Study Chair: William E. Boden, VA South Texas Health Care System, San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

December 29, 2000

First Submitted That Met QC Criteria

January 3, 2001

First Posted (Estimate)

January 4, 2001

Study Record Updates

Last Update Posted (Estimate)

June 15, 2009

Last Update Submitted That Met QC Criteria

June 12, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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