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
Funders
Funder type
Industry
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: PCT-15191)
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Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development (USA)
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Merck and Co. Inc. (USA)
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Pfizer Pharmaceuticals (USA)
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Bristol-Meyers Squibb Medical Imaging (USA)
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Fujisawa Pharmaceuticals (UK)
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Kos Pharmaceuticals (USA)
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Datascope (USA)
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AstraZeneca (USA)
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private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
Key Pharmaceuticals (Australia)
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Sanofi-Aventis (USA)
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First Horizon (USA)
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Nycomed Amersham (UK)
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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
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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.
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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.
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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.
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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.