NCT00402506

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2007

First QC Date

November 20, 2006

Last Update Submit

November 15, 2007

Conditions

Coronary Artery Bypass Graft SurgeryMyocardial IschemiaReperfusion Injury

Keywords

coronarysurgeryischemiareperfusion injurycardiacheartneurologicalcardiopulmonary bypasscardioprotectionmyocardiummyocardialmyocardial revascularization

Outcome Measures

Primary Outcomes (1)

  • combined incidence of cardiovascular death or nonfatal myocardial infarction on days up to and including post-operative day (POD) 30

Secondary Outcomes (3)

  • length of hospital stay for index hospitalization

  • length of stay in intensive care unit (ICU) or coronary care unit (CCU) for index hospitalization

  • incidence of cardiovascular death up to and including POD 90

Interventions

(MC-1) Pyridoxal 5'-phosphateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)
  • +4 more criteria

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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke Clinical Research Institute

Durham, North Carolina, 27705, United States

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (3)

  • Kandzari DE, Labinaz M, Cantor WJ, Madan M, Gallup DS, Hasselblad V, Joseph D, Allen A, Green C, Hidinger KG, Krucoff MW, Christenson RH, Harrington RA, Tcheng JE. Reduction of myocardial ischemic injury following coronary intervention (the MC-1 to Eliminate Necrosis and Damage trial). Am J Cardiol. 2003 Sep 15;92(6):660-4. doi: 10.1016/s0002-9149(03)00818-x.

    PMID: 12972102BACKGROUND

  • MEND-CABG II Investigators; Alexander JH, Emery RW Jr, Carrier M, Ellis SJ, Mehta RH, Hasselblad V, Menasche P, Khalil A, Cote R, Bennett-Guerrero E, Mack MJ, Schuler G, Harrington RA, Tardif JC. Efficacy and safety of pyridoxal 5'-phosphate (MC-1) in high-risk patients undergoing coronary artery bypass graft surgery: the MEND-CABG II randomized clinical trial. JAMA. 2008 Apr 16;299(15):1777-87. doi: 10.1001/jama.299.15.joc80027. Epub 2008 Apr 1.

    PMID: 18381567DERIVED

  • Mehta RH, Alexander JH, Emery R, Ellis SJ, Hasselblad V, Khalil A, Carrier M, Harrington RA, Tardif JC; MEND-CABG II Investigators. A randomized, double-blind, placebo-controlled, multicenter study to evaluate the cardioprotective effects of MC-1 in patients undergoing high-risk coronary artery bypass graft surgery: MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery Trial (MEND-CABG) II--study design and rationale. Am Heart J. 2008 Apr;155(4):600-8. doi: 10.1016/j.ahj.2008.01.002. Epub 2008 Feb 21.

    PMID: 18371465DERIVED

MeSH Terms

Conditions

Myocardial IschemiaReperfusion InjuryIschemiaNeurologic Manifestations

Interventions

Pyridoxal Phosphate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

PyridoxalVitamin B 6PicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Michel Carrier, MD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

  • Robert A Harrington, MD

    Duke Clinical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

November 1, 2006

Study Completion

September 1, 2007

Last Updated

November 16, 2007

Record last verified: 2007-11

Locations

US(1)CA(1)