Prevention of systemic inflammatory response predominantly triggered by the interaction between the patient’s blood and the pump’s artificial surfaces in patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass. This is manifested as an increase in mortality and myocardial infarction. MedDRA version: 7.0 Level: PT Classification code 10006894
Conditions
Interventions
Product Name: pexelizumab
Product Code: h5G1.1-scFv
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injecti
Sponsors
Procter & Gamble Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
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: a. be at least 18 years of age; b. have 2 or more of the following risk factors: i) diabetes mellitus; ii) repeat CABG; iii) the need for urgent intervention, defined according to the ACC/AHA guidelines as being patients who are required to stay in the hospital due to medical factors, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had an MI within 48 hours of CABG; iv) female; v) history of a neurologic event (cerebrovascular accident, transient ischemic attack or carotid endarterectomy); vi) history of congestive heart failure (NYHA CHF Class III or IV); vii) history of 2 or more MIs, or a MI that occurred greater than 48 hours but less than 4 weeks prior to CABG; c. provide Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. requires salvage intervention as defined by the ACC/AHA guidelines10 as being ongoing cardiopulmonary resuscitation on the way to the operating room; b. has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture; c. 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); d. has a known or suspected hereditary complement deficiency; e. has participated in any other investigational drug study or was exposed to an investigational agent or device within 30 days of randomization; f. is receiving, or is planning to receive, any other investigational drug or device, or will participate in any other research study within 30 days of randomization; g. is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of pexelizumab on the following endpoint: • composite endpoint of all-cause mortality or MI through post operative day (POD) 30. ;Primary end point(s): Reduction of the composite of all-cause mortality or MI through POD 30.; Secondary Objective: To assess the clinical impact of pexelizumab on: • all-cause mortality at POD 90 • new or worsening congestive heart failure (CHF) occurring during the index hospitalization or re-hospitalization for CHF up to and including POD 30. The tertiary objectives are as follows: • all-cause mortality at POD 180. • worsening of NYHA score from baseline at POD 30; • resource utilization • total chest tube drainage (from time of chest tube insertion to chest tube removal). | — |
Countries
United Kingdom
Outcome results
None listed