A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG

Completed · Phase 3

Conditions studied: Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury

In brief

The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG) surgery compared with placebo.

Key facts

Study ID

NCT00402506

Run by

Medicure

People needed

3000

Starts

2006-11-01

Expected to finish

2007-09-01

Last updated by the study team

2007-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be scheduled to undergo CABG surgery (during routine scheduling times) and had planned to use cardiopulmonary bypass.
• Provide informed consent
• Age ≥ 18
• Male patients, or female patients not of childbearing potential or who have had a negative pregnancy test and are practicing adequate contraception
• Patients must be considered at high risk for subsequent myocardial complications defined as meeting 2 or more of the following:
• Age ≥ 65
• Current or recent smoker (within last 6 months)
• History of diabetes mellitus requiring treatment other than diet
• Evidence of left ventricular dysfunction or congestive heart failure assessed by:
• Ejection fraction (EF) ≤ 45%
• Left ventricular end diastolic pressure (LVEDP) or pulmonary wedge pressure (PWP) ≥ 20 mm Hg
• Pulmonary edema by chest X-ray
• Cardiothoracic ratio > 50% on chest X-ray
• History of a previous non-disabling stroke, transient ischemic attack, or carotid endarterectomy
• Urgent CABG intervention defined as the need to stay in the hospital (although patient may be operated on within a normal scheduling routine)
• History of a myocardial infarction that occurred more than 48 hours but less than 6 weeks prior to CABG surgery
• Prior peripheral artery surgery or angioplasty
• Moderate renal dysfunction defined as creatinine clearance ≥ 30 ml/min, but < 60 ml/min
• Presence of at least one asymptomatic carotid artery stenosis (≥ 50%) either in one or two carotid arteries

You may not qualify if…

• Planned associated valve surgery or concurrent carotid endarterectomy
• Planned aortic dissection repair or aortic root reconstruction
• Screening visit occurring less than 4 hours before scheduled CABG surgery
• Mini-Mental State Examination (MMSE) score less than 24 at the screening visit
• Current cardiogenic shock, acute left ventricular rupture, ventricular septal rupture, or papillary muscle rupture
• Uncontrolled diabetes defined as fasting serum blood glucose value equal to or greater than 24 mmol/L (432 mg/dl) at the time of screening (if fasting serum blood glucose not obtained at screening, values obtained within 30 days prior to screening visit may be used)
• Myocardial infarction occurring < 48 hours prior to planned CABG surgery
• Severe renal dysfunction defined as an estimated creatinine clearance value of < 30 ml/min or nephrotic syndrome at screening (or measured creatinine clearance value obtained within 30 days prior to screening visit)
• History of liver cirrhosis, chronic active hepatitis (known positive serum test within 6 months of enrolment), or severe liver dysfunction; or liver transaminase ≥ 3 times upper limit of normal (ULN) at screening (or obtained within 30 days prior to screening visit).
• History of malignancy during last 5 years except for basal cell carcinoma
• Planned surgery for atrial fibrillation
• Planned associated transmyocardial revascularization
• Planned associated ventricular remodeling
• Pregnancy or potential for pregnancy
• Any medical or psychiatric condition which, in the opinion of the investigator, makes the patient an unsuitable candidate for the study
• Significant, ongoing alcohol or drug abuse
• Participation in any other investigational drug or device study within 30 days of randomization

Where it is running

• Duke Clinical Research Institute — Durham, North Carolina, United States
• Montreal Heart Institute — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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