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Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass | Clinical Trials | Clareo Health

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Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass

NCT00048308•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Exclusion Criteria

•has planned aortic dissection repair and/or requires aortic root reconstruction;
•requires salvage intervention as defined by the ACC/AHA guidelines as being ongoing cardiopulmonary resuscitation on the way to the operating room;
•has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture;
•has uncontrolled diabetes, defined as a documented plasma blood glucose value \> 400 mg/dl (22.2 mmol/L) within three (3) days before surgery;
•has a history of renal failure and a serum creatinine value greater than 3.0 mg/dl;
•has a history of chronic hepatic failure and/or hepatic cirrhosis;
•has a history of malignancy, excepting basal cell carcinoma and malignancies in remission (greater than 2 years);
•has any active bacterial or other infection which is clinically significant, in the opinion of the investigator (e.g. evaluate the evidence based on WBC, temperature, cultures, etc. as appropriate for the patient);
•has any serious medical condition which, in the opinion of the investigator is likely to alter the patient's course of recovery or the evaluation of the study medication's safety;
•has a history of alcohol or drug abuse within the past year;
+4 more criteria

Locations (186)

Baptist Medical Center Cardiology

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

IMC-Diagnostic and Medical Clinic

Mobile, Alabama, United States

Desert Samaritan - Lutheran Heart

Mesa, Arizona, United States

Good Samaritan Regional Medical Center

Phoenix, Arizona, United States

Saguaro Clinical Research

Tucson, Arizona, United States

Southern Arizona VAMC

Tucson, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

University of Arkansas

Little Rock, Arkansas, United States

Key Dates

Start Date

January 1, 2002

Primary Completion Date

March 1, 2003

Last Updated

February 23, 2017

Enrollment

3,000

Estimated participants

Conditions

Cardio-pulmonary BypassCoronary Artery Bypass Graft

Interventions

pexelizumab

DRUG

Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization

NCT06645327

Coronary Artery Bypass Grafting Surgery (CABG)

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RECRUITINGNA

Effect of Nurse-Led Education and Tele-Interventions on Reducing Surgical Site Infections in Patients After Coronary Artery Bypass Surgery: a Clinical Trial

NCT06586749

Surgical Site InfectionCoronary Artery Bypass Grafting (CABG)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass

Inclusion Criteria

Exclusion Criteria

Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization

Effect of Nurse-Led Education and Tele-Interventions on Reducing Surgical Site Infections in Patients After Coronary Artery Bypass Surgery: a Clinical Trial

Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.

Remimazolam for Postoperative Atrial Fibrillation

Effect of Early Low Resisted Exercise With Blood Flow Restriction on Pulmonary Function in Post Cardiac Surgery Patient

Cardioplegic Protection of the Heart