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
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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