Clinical Outcomes Utilising Revascularisation and Aggressive Drug Evaluation
| ISRCTN | ISRCTN18172323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18172323 |
| ClinicalTrials.gov number | NCT00007657 |
| Secondary identifying numbers | PCT-15191 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 23/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Koon Kang Teo
Scientific
Scientific
3U4 McMaster University Medical Centre
1200 Main Street West
Hamilton
L8N 3Z5
Canada
| Phone | +1 905-905-521-2100 (76222) |
|---|---|
| teok@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | COURAGE |
| Study objectives | 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(s) | Ethics approval received from the Research Ethics Board of McMaster University on the 8th September 1999. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/1999 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2546 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/06/1999 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centre
3U4 McMaster University Medical Centre
Hamilton
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
Department of Veteran Affairs, U.S. Federal Government and McMaster University Faculty of Health Sciences (Canada)
Not defined
Not defined
Ms Marie Townsend
Administrator
Research Programs
1200 Main Street West
Hamilton
L8N 3Z5
Canada
"ROR" |
https://ror.org/02fa3aq29 |
|---|
Funders
Funder type
Industry
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: PCT-15191)
No information available
Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development (USA)
No information available
Merck and Co. Inc. (USA)
No information available
Pfizer Pharmaceuticals (USA)
No information available
Bristol-Meyers Squibb Medical Imaging (USA)
No information available
Fujisawa Pharmaceuticals (UK)
No information available
Kos Pharmaceuticals (USA)
No information available
Datascope (USA)
No information available
AstraZeneca (USA)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Key Pharmaceuticals (Australia)
No information available
Sanofi-Aventis (USA)
No information available
First Horizon (USA)
No information available
Nycomed Amersham (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/01/2007 | Yes | No | |
| Results article | results | 29/09/2009 | Yes | No | |
| Results article | results | 30/03/2010 | Yes | No | |
| Results article | results | 01/02/2014 | Yes | No |
