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

NCT00402506 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2007-11-16

No results posted yet for this study

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.

Conditions

  • Coronary Artery Bypass Graft Surgery
  • Myocardial Ischemia
  • Reperfusion Injury

Interventions

DRUG

(MC-1) Pyridoxal 5'-phosphate

Sponsors & Collaborators

  • Medicure

    lead INDUSTRY

Principal Investigators

  • Michel Carrier, MD · Montreal Heart Institute

  • Robert A Harrington, MD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Completion
2007-09-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00402506 on ClinicalTrials.gov