Condition category
Circulatory System
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
23/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Koon Kang Teo

ORCID ID

Contact details

3U4 McMaster University Medical Centre
1200 Main Street West
Hamilton
L8N 3Z5
Canada
+1 905-905-521-2100 (76222)
teok@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00007657

Protocol/serial number

PCT-15191

Study information

Scientific title

Acronym

COURAGE

Study hypothesis

Primary Hypothesis:
The strategy of Percutaneous Coronary Intervention (PCI) plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality, non-fatal Myocardial Infarction (MI) or biomarker positive (troponin) acute coronary syndrome patients with documented myocardial ischaemia who meet an American Heart Association (AHA) task force Class I indication for PCI.

Secondary Hypothesis:
Resource utilisation and Quality Of Life (QOL) comparisons and hospitalisation for unstable angina will be superior in PCI plus medical therapy compared to medical therapy alone.

Ethics approval

Ethics approval received from the Research Ethics Board of McMaster University on the 8th September 1999.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Myocardial Ischaemia

Intervention

Both groups: Intensive medical therapy
Experimental group: Percutaneous coronary intervention beside the intensive medical therapy

Trial details received: 12 September 2005

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Composite of all causes mortality, non-fatal MI and hospitalised acute coronary syndrome with biomarkers (troponin) positively.

Secondary outcome measures

1. Quality of life, assessed at regular intervals during the trial
2. Resource utilisation: Comprehensive information on health care used by COURAGE participants, including the direct in-hospital cost of PCI, other healthcare costs, and indirect costs incurred by patients
3. Hospitalisation for unstable arginia with negative biomarkers

Overall trial start date

01/06/1999

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (greater than or equal to 18 years old, either sex) 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, and asymptomatic (or 'silent') myocardial ischaemia. Patients may have single - or multi-vessel coronary artery disease and may have had prior bypass graft surgery. It is important to emphasize that as many types of Coronary Heart Disease (CHD) patients as possible - reflecting the spectrum of patients encountered in contemporary clinical practice - will be enrolled in COURAGE.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2546

Participant exclusion criteria

1. Unstable angina and symptoms refractory to maximal oral and intravenous medical therapy (persistent CCS Class IV)
2. Post-MI course complicated by persistent rest angina, shock, and persistent CHF for which the need or likelihood of urgent myocardial revascularisation is high
3. Coronary angiographic exclusions:
3.1. Patients with no prior Coronary Artery Bypass Graft (CABG) and left main coronary disease greater than 50%
3.2. Coronary arteries technically unsuitable or hazardous for PCI
3.3. Patients with non-significant coronary artery disease in whom PCI would not be considered appropriate or indicated
3.4. Ejection fraction less than 30%, except less than 35% if patients has three-vessel disease including greater than 70% Left Anterior Descending (LAD) proximal stenosis
3.5. Cardiogenic shock
3.6. Pulmonary edema or CHF unresponsive to standard medical therapy
3.7. CABG or PCI within the last 6 months
3.8. Concomitant valvular heart disease likely to require surgery or affect prognosis during follow-up
3.9. Congenital or primary cardiac muscle disease likely to affect prognosis during follow-up
3.10. Resuscitated out-of-hospital sudden death or symptomatic sustained or non-sustained ventricular tachycardia
3.11. Significant systemic hypertension (Blood Pressure [BP] greater than 200/100 mmHg) unresponsive to medical therapy

Recruitment start date

01/06/1999

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

3U4 McMaster University Medical Centre
Hamilton
L8N 3Z5
Canada

Sponsor information

Organisation

Department of Veteran Affairs, U.S. Federal Government and McMaster University Faculty of Health Sciences (Canada)

Sponsor details

Ms Marie Townsend
Administrator
Research Programs
1200 Main Street West
Hamilton
L8N 3Z5
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: PCT-15191)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development (USA)

Alternative name(s)

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Location

Funder name

Merck and Co. Inc. (USA)

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Pfizer Pharmaceuticals (USA)

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Funder name

Bristol-Meyers Squibb Medical Imaging (USA)

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Funder name

Fujisawa Pharmaceuticals (UK)

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Kos Pharmaceuticals (USA)

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Datascope (USA)

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AstraZeneca (USA)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Key Pharmaceuticals (Australia)

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Location

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Sanofi-Aventis (USA)

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First Horizon (USA)

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Funder name

Nycomed Amersham (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17223420
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19778673
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20338496
4. 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24440015

Publication citations

  1. Protocol

    Boden WE, O'rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk W, Knudtson M, Dada M, Casperson P, Harris CL, Spertus JA, Shaw L, Chaitman BR, Mancini GB, Berman DS, Gau G, Weintraub WS, , The evolving pattern of symptomatic coronary artery disease in the United States and Canada: baseline characteristics of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial., Am. J. Cardiol., 2007, 99, 2, 208-212, doi: 10.1016/j.amjcard.2006.07.082.

  2. Results

    Teo KK, Sedlis SP, Boden WE, O'Rourke RA, Maron DJ, Hartigan PM, Dada M, Gupta V, Spertus JA, Kostuk WJ, Berman DS, Shaw LJ, Chaitman BR, Mancini GB, Weintraub WS, , Optimal medical therapy with or without percutaneous coronary intervention in older patients with stable coronary disease: a pre-specified subset analysis of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) trial., J. Am. Coll. Cardiol., 2009, 54, 14, 1303-1308, doi: 10.1016/j.jacc.2009.07.013.

  3. Results

    Maron DJ, Boden WE, O'Rourke RA, Hartigan PM, Calfas KJ, Mancini GB, Spertus JA, Dada M, Kostuk WJ, Knudtson M, Harris CL, Sedlis SP, Zoble RG, Title LM, Gosselin G, Nawaz S, Gau GT, Blaustein AS, Bates ER, Shaw LJ, Berman DS, Chaitman BR, Weintraub WS, Teo KK, , Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial., J. Am. Coll. Cardiol., 2010, 55, 13, 1348-1358, doi: 10.1016/j.jacc.2009.10.062.

  4. Results

    Mancini GB, Hartigan PM, Shaw LJ, Berman DS, Hayes SW, Bates ER, Maron DJ, Teo K, Sedlis SP, Chaitman BR, Weintraub WS, Spertus JA, Kostuk WJ, Dada M, Booth DC, Boden WE, Predicting outcome in the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation): coronary anatomy versus ischemia., JACC Cardiovasc Interv, 2014, 7, 2, 195-201, doi: 10.1016/j.jcin.2013.10.017.

Additional files

Editorial Notes