For treatment to reduce cardiovascular events associated with ischemic damage and/or ischemia-reperfusion injury in patients undergoing CABG surgery. MedDRA version: 8.1 Level: LLT Classification code 10051624 Term: Myocardial reperfusion injury
Conditions
Interventions
Product Name: MC-1
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Pyridoxal 5'-Phosphate (P5P) monohydrate
CAS Number: 41468-25-1
Current Sponsor code: MC-1
Concentration unit: mg milligram(s
Sponsors
Medicure International Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Provide informed consent • Patients who are =18 years of age • Male patients, or female patients who are not of childbearing potential or female patients who have had a negative pregnancy test and are practicing adequate contraception • Patients must be scheduled to undergo CABG surgery with planned cardiopulmonary bypass, during routine scheduling times • Patients must be considered at “high-risk” for subsequent myocardial complications defined as meeting TWO OR MORE of the following criteria : o Age = 65 years o Current or recent smoker (within the last 6 months) o History of diabetes mellitus requiring treatment other than diet o Evidence of left ventricular dysfunction or congestive heart failure o History of a previous non-disabling stroke, transient ischemic attack, or carotid endarterectomy o Urgent CABG intervention defined as the need to stay in the hospital o History of MI that occurred more than 48 hours but less than 6 weeks prior to CABG surgery o Prior peripheral artery surgery or angioplasty o Moderate renal dysfunction defined as creatinine clearance > 30 ml/min, but 50%) either in one or two carotid arteries Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • 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) • MI occurring <48 hours prior to planned CABG surgery • Severe renal dysfunction defined as an estimated creatinine clearance value <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 known liver transaminase =3 times ULN • History of malignancy during the last 5 years except for basal cell carcinoma • Planned surgery for atrial fibrillation • Planned associated transmyocardial revascularization • Planned associated ventricular remodeling • Pregnancy, as determined by a pregnancy test • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective 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 CABG surgery compared with placebo.;Secondary Objective: The secondary objectives of this study are to determine: • Length of hospital stay for index hospitalization • Length of stay in ICU/coronary care unit (CCU) for index hospitalization • Incidence of cardiovascular death up to and including post operative day 90 (POD 90) Additional pre-specified secondary endpoints will include: • Incidence of cardiovascular death or nonfatal MI up to and including POD 90; • Incidence of cardiovascular death up to and including POD 4 and POD 30; • Incidence of nonfatal MI up to and including POD 4, POD 30, and POD 90; • Incidence of nonfatal cerebral infarction up to and including POD 4, POD 30, and POD 90; • Incidence of all-cause mortality up to and including POD 4, POD 30, and POD 90; • MMSE score at POD 30 and POD 90 (MMSE score among patients whose MMSE at screening was =27); • CK-MB AUC (0-24 hours) (CK-MB AUC (0-24 hours) among patients who had a nonfatal MI);Primary end point(s): The primary endpoint will be the incidence of cardiovascular death or nonfatal MI up to and including post-operative day (POD) 30. Nonfatal MI will be defined as a peak creatine kinase myocardial band (CK-MB) level =100 ng/ml up to and including POD 4, or a new 30 ms q-wave in 2 contiguous leads along with CK-MB of =70 ng/ml on days up to and including POD 4, or a new peak CK-MB of =25 ng/ml or above occurring after POD 4, or a new 30 ms q-wave in 2 contiguous leads that was not present at POD 4, or a q-wave or non-q-wave MI as identified by the investigator and confirmed by the Clinical Endpoint Committee (CEC). | — |
Countries
Germany
Outcome results
None listed