Clinical Outcomes Utilising Revascularisation and Aggressive Drug Evaluatio

Completed

• Conditions: Ischaemic diseases; Myocardial Ischaemia; Circulatory System

• Registration Number: ISRCTN18172323
• Lead Sponsor: Department of Veteran Affairs, U.S. Federal Government and McMaster University Faculty of Health Sciences (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2546

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified