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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/24/2018
Start Date:July 2004
End Date:October 2005

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A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

During a heart bypass procedure, a substance called "complement" is activated by the body.
This "complement activation" causes an inflammatory response that can lead to side affects
such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study
is to find out if the study drug (pexelizumab), that blocks "complement activation," can
reduce such side effects and be given safely to patients requiring the bypass procedure with
the use of the heart-lung machine.


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.
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Oklahoma City, Oklahoma 73104
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
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3300 Gallows Road
Falls Church, Virginia 22042
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1200 North Elm Street
Greensboro, North Carolina 27401
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Jacksonville, Florida 32207
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777 Hemlock Street
Macon, Georgia 31201
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Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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1414 Kuhl Avenue
Orlando, Florida 32806
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22 Bramhall St
Portland, Maine 04102
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601 Elmwood Avenue
Rochester, New York 14642
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1 Akron General Ave
Akron, Ohio 44307
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Arlington, Virginia 22205
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
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1364 Clifton Rd NE
Atlanta, Georgia 30322
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5301 South Congress Avenue
Atlantis, Florida 33462
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Austin, Texas 78756
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3001 Sillect Avenue
Bakersfield, California 93301
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Baltimore, Maryland 21215
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Bend, Oregon 97701
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3 Boulevard A. Fleming
Besancon, 25030
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800 Montclair Road
Birmingham, Alabama 35213
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50 Medical Park East Drive
Birmingham, Alabama 35235
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Bridgeport, Connecticut 06606
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4802 10th Avenue
Brooklyn, New York 11219
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Camden, New Jersey 08103
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Charleston, West Virginia 25304
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1215 Lee St
Charlottesville, Virginia 22903
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2139 Auburn Ave
Cincinnati, Ohio 45219
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Clearwater, Florida 33756
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11100 Euclid Avenue
Cleveland, Ohio 44106
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3535 Olentangy River Rd
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1900 Sullivan Avenue
Daly City, California 94015
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Dayton, Ohio 45408
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Decatur, Georgia 30033
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Denver, Colorado 80218
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Denver, Colorado 80210
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Houston, Texas 77030
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33-57 Harrison Street
Johnson City, New York 13790
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1521 Gull Rd
Kalamazoo, Michigan 49048
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Lexington, Kentucky 40503
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