Cardio-pulmonary Bypass, Coronary Artery Bypass Graft
Conditions
Keywords
CABG
Brief summary
During a heart bypass procedure, a substance called complement is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, heart failure, or impairment of memory, language and motor skills. The purpose of this study is to find out if the study drug (pexelizumab), which blocks complement release, can reduce such side effects and be taken safely.
Interventions
DRUGpexelizumab
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study population will be drawn from patients undergoing CABG or CABG plus valve surgery using a bypass pump. In addition, they must meet all of the following criteria: * be at least 18 years of age; * have one or more of the following risk factors: * diabetes mellitus; * prior CABG; * the need for urgent intervention, defined according to the American College of Cardiology/ American Heart Association (ACC/AHA) guidelines as being patients who are required to stay in the hospital, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had a MI within 48 hours of CABG; * female; * history of a neurologic event (cerebrovascular accident, transient ischemic attack or carotid endarterectomy); * history of congestive heart failure (New York Heart Association \[NYHA\]Class III or IV); * history of 2 myocardial infarctions, or a myocardial infarction that occurred greater than 48 hours but less than four (4) weeks prior to CABG; * provide Informed Consent.
Exclusion criteria
A patient will be ineligible for study entry if he/she meets any of the following
Countries
Canada, United States
Outcome results
None listed