Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

Inclusion Criteria:

• be at least 18 years of age;

• have 2 or more of the following risk factors:

• diabetes mellitus; • repeat CABG; • the need for urgent intervention, definedaccording to the ACC/AHA guidelines as being patients who are required to stay in thehospital due to medical factors, but may be scheduled and operated on within a normalscheduling routine, excluding patients who have had an MI within 48 hours of CABG; •female; • history of a neurologic event (cerebrovascular accident, transient ischemicattack or carotid endarterectomy); • history of congestive heart failure (NYHA CHFClass III or IV); • history of 2 MIs, or an MI that occurred greater than 48 hours butless than 4 weeks prior to CABG;

• provide Informed Consent.

Exclusion Criteria:

• requires salvage intervention as defined by the ACC/AHA guidelines 10 as being ongoingcardiopulmonary resuscitation on the way to the operating room;

• has current cardiogenic shock, acute left ventricular rupture, acute septal rupture oracute papillary muscle rupture;

• has any active bacterial or other infection which is clinically significant, in theopinion of the Investigator (e.g. evaluate the evidence based on WBC, temperature,cultures etc. as appropriate for the patient);

• has a known or suspected hereditary complement deficiency;

• has participated in any other investigational drug study or was exposed to aninvestigational agent or device within 30 days of randomization;

• is receiving, or is planning to receive, any other investigational drug or device, orwill participate in any other research study within 30 days of randomization;

• is pregnant or breast-feeding.