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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicure
• Treatments: Pyridoxal; Pyridoxal Phosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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