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, 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; •
female; • history of a neurologic event (cerebrovascular accident, transient ischemic
attack or carotid endarterectomy); • history of congestive heart failure (NYHA CHF
Class III or IV); • history of 2 MIs, or an MI that occurred greater than 48 hours but
less than 4 weeks prior to CABG;

- provide Informed Consent.

Exclusion Criteria:

- requires salvage intervention as defined by the ACC/AHA guidelines 10 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 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 a known or suspected hereditary complement deficiency;

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

- 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;

- is pregnant or breast-feeding.