A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoin… (NCT00402506) | Clinical Trial Compass
CompletedPhase 3
A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG
United States, Canada3,000 participantsStarted 2006-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%) eith…
What they're measuring
1
combined incidence of cardiovascular death or nonfatal myocardial infarction on days up to and including post-operative day (POD) 30