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Clinical Trials/ISRCTN18172323
ISRCTN18172323
Completed
Not Applicable

Clinical Outcomes Utilising Revascularisation and Aggressive Drug Evaluatio

Department of Veteran Affairs, U.S. Federal Government and McMaster University Faculty of Health Sciences (Canada)0 sites2,546 target enrollmentSeptember 26, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Department of Veteran Affairs, U.S. Federal Government and McMaster University Faculty of Health Sciences (Canada)
Enrollment
2546
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 26, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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