Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass
Sponsor
Alexion Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00048308
Collaborator
(none)
3,000
186
16.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Actual Study Start Date
:
Jan 1, 2002
Actual Primary Completion Date
:
Mar 1, 2003
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;
-
provide Informed Consent.
EXCLUSION CRITERIA:
A patient will be ineligible for study entry if he/she meets any of the following 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;
-
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 during the trial;
-
is pregnant or breast-feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baptist Medical Center Cardiology | Birmingham | Alabama | United States | 35211 |
| 2 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35249-6880 |
| 3 | IMC-Diagnostic and Medical Clinic | Mobile | Alabama | United States | 36604 |
| 4 | Desert Samaritan - Lutheran Heart | Mesa | Arizona | United States | 85202 |
| 5 | Good Samaritan Regional Medical Center | Phoenix | Arizona | United States | 85006 |
| 6 | Saguaro Clinical Research | Tucson | Arizona | United States | 85712 |
| 7 | Southern Arizona VAMC | Tucson | Arizona | United States | 85723 |
| 8 | University of Arizona | Tucson | Arizona | United States | 85724 |
| 9 | Sparks Regional Medical Center | Fort Smith | Arkansas | United States | 72901 |
| 10 | University of Arkansas | Little Rock | Arkansas | United States | 72205 |
| 11 | Brotman Medical Center | Beverly Hills | California | United States | 90210 |
| 12 | Cardiovascular Associates of the Peninsula | Burlingame | California | United States | 94401 |
| 13 | Seton Medical Center | Daly City | California | United States | 94015 |
| 14 | St. Jude Medical Center | Fullerton | California | United States | 92835 |
| 15 | Apex Cardiology | Inglewood | California | United States | 90301 |
| 16 | Huntington Memorial Hospital | Los Angeles | California | United States | 90033 |
| 17 | University of Southern California | Los Angeles | California | United States | 90033 |
| 18 | St. Vincent's Hospital | Los Angeles | California | United States | 90057 |
| 19 | University of California - Los Angeles | Los Angeles | California | United States | 90095 |
| 20 | Crozer-Chester Medical Center | Oakland | California | United States | 94609-3102 |
| 21 | Tri-City Medical Center | Oceanside | California | United States | 92056 |
| 22 | Mercy General Hospital | Sacramento | California | United States | 95819 |
| 23 | San Diego Cardiac Center | San Diego | California | United States | 92123 |
| 24 | Kaiser Foundation Hospital | San Francisco | California | United States | 94115 |
| 25 | UCSF Moffitt-Long Hospital | San Francisco | California | United States | 94143 |
| 26 | South Denver Cardiology Associates | Denver | Colorado | United States | 80111 |
| 27 | Western Cardiology Associates | Denver | Colorado | United States | 80218 |
| 28 | Heart and Vascular Clinic of Northern CO | Fort Collins | Colorado | United States | 80528 |
| 29 | St. Vincent's Medical Center | Bridgeport | Connecticut | United States | 06606 |
| 30 | Bridgeport Hospital | Bridgeport | Connecticut | United States | 06610 |
| 31 | Christiana Care Health Services | Newark | Delaware | United States | 19718 |
| 32 | Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 33 | Cardiology Associates | Washington | District of Columbia | United States | 20010 |
| 34 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 35 | VA Medical Center - Washington DC | Washington | District of Columbia | United States | 20422 |
| 36 | Florida Cardiovascular Research | Atlantis | Florida | United States | 33462 |
| 37 | Morton Plan Mease Health Care | Clearwater | Florida | United States | 33756 |
| 38 | Heart Group Research | Fort Lauderdale | Florida | United States | 33308 |
| 39 | Gulf Bay Cardiovascular and Thoracic Associates | Hudson | Florida | United States | 34563 |
| 40 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 41 | MIMA Century Research Associates | Melbourne | Florida | United States | 32901 |
| 42 | Brevard Cardiology Group, PA | Merritt Island | Florida | United States | 32953 |
| 43 | Medical Research Unlimited | Miami | Florida | United States | 33125 |
| 44 | Florida Heart Institute at Florida Hospital | Orlando | Florida | United States | 32803 |
| 45 | Orlando Heart Center | Orlando | Florida | United States | 32806 |
| 46 | Cardiology Consultants | Pensacola | Florida | United States | 32504 |
| 47 | Ford Research Center | Pensacola | Florida | United States | 32514 |
| 48 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34239 |
| 49 | Northside Hospital ans Heart Institute | St. Petersburg | Florida | United States | 33709 |
| 50 | Tallahassee Memorial Regional Medical Center | Tallahassee | Florida | United States | 32308 |
| 51 | Pepin Heart and Vascular Institute | Tampa | Florida | United States | 33613 |
| 52 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
| 53 | St. Joseph's Hospital | Atlanta | Georgia | United States | 30342 |
| 54 | University Hospital | Augusta | Georgia | United States | 30901 |
| 55 | VA Medical Center- Atlanta | Decatur | Georgia | United States | 30033 |
| 56 | VA Medical Center - Dubin | Macon | Georgia | United States | 31208 |
| 57 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813-3009 |
| 58 | Kaiser Permanente Medical Center | Honolulu | Hawaii | United States | 96819 |
| 59 | Northwestern Univ. Medical Center | Chicago | Illinois | United States | 60611 |
| 60 | Northwestern University Medical Center | Chicago | Illinois | United States | 60611 |
| 61 | University of Illinois - Chicago | Chicago | Illinois | United States | 60612 |
| 62 | Evanston Northwestern Healthcare Evanston Hospital | Evanston | Illinois | United States | 60201 |
| 63 | Indiana Ohio Heart | Fort Wayne | Indiana | United States | 46804 |
| 64 | Community Hospital | Indianapolis | Indiana | United States | 46219 |
| 65 | St. Vincent's Medical Center | Indianapolis | Indiana | United States | 46260 |
| 66 | Iowa Heart Center - Laurel | Des Moines | Iowa | United States | 50314 |
| 67 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 68 | University of Kansas City Medical Center | Kansas City | Kansas | United States | 66160-7378 |
| 69 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 70 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 71 | University of Louisville | Louisville | Kentucky | United States | 40292 |
| 72 | Cardiovascular Institute of the South | Houma | Louisiana | United States | 70360 |
| 73 | Turuo Infirmary | New Orleans | Louisiana | United States | 70115 |
| 74 | Methodist Hospital | New Orleans | Louisiana | United States | 70118 |
| 75 | Alton Ochsner Medical Foundation - Brent House | New Orleans | Louisiana | United States | 70121 |
| 76 | Cardiac Centers of Louisiana | Shreveport | Louisiana | United States | 711033 |
| 77 | Cardiovascular Institute of the South | Thibodaux | Louisiana | United States | 70301 |
| 78 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 79 | Union Memorial Hospital | Baltimore | Maryland | United States | 21218 |
| 80 | Washington Adventist Hospital | Takoma Park | Maryland | United States | 20912 |
| 81 | Midatlantic Cardiovascular Associates | Towson | Maryland | United States | 21204 |
| 82 | St. Joseph's Hospital | Towson | Maryland | United States | 21204 |
| 83 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 84 | Brigham and Womens Hospital | Boston | Massachusetts | United States | 02115 |
| 85 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 86 | University of Massachusetts | Worcester | Massachusetts | United States | 01655 |
| 87 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 88 | McLaren Regional Medical Center | Flint | Michigan | United States | 48532 |
| 89 | Thoracic and Cardiovascular Institute | Lansing | Michigan | United States | 48919 |
| 90 | West Shore Cardiology Research Department | Muskegon | Michigan | United States | 46444 |
| 91 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 92 | Covenant Medical Center | Saginaw | Michigan | United States | 48602 |
| 93 | St. Luke's Hospital-Duluth | Duluth | Minnesota | United States | 55805 |
| 94 | St. Mary's Duluth Health System | Duluth | Minnesota | United States | 55805 |
| 95 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 96 | Park Nicollet Medical Center | Minneapolis | Minnesota | United States | 55416 |
| 97 | North Memorial Hospital | Robbinsdale | Minnesota | United States | 55422 |
| 98 | Park Nicollet Health Research Center | St. Louis Park | Minnesota | United States | 55426 |
| 99 | Mississippi Center for Clinical Research | Jackson | Mississippi | United States | 32216 |
| 100 | St. Luke's Hospital - Mid-America Heart Institute | Kansas City | Missouri | United States | 64111 |
| 101 | Christian North East Hospital | St. Louis | Missouri | United States | 63110 |
| 102 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
| 103 | Cardiology diagnostics, Ltd. | St. Peters | Missouri | United States | 63376 |
| 104 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 105 | Cardiovascular Associates of the Delaware Valley | Haddon Heights | New Jersey | United States | 08035 |
| 106 | Garden State Cardiology | Paramus | New Jersey | United States | 07652 |
| 107 | Albert Einstein Hospital | Bronx | New York | United States | 10461 |
| 108 | Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
| 109 | United Health Services | Johnson City | New York | United States | 13790 |
| 110 | New York Presbyterian Hospital | New York City | New York | United States | 10021 |
| 111 | Rochester General Hospital | Rochester | New York | United States | 14621 |
| 112 | University of Rochester | Rochester | New York | United States | 14642 |
| 113 | Westchester County Medical Center | Valhalla | New York | United States | 10595 |
| 114 | Asheville Cardiothoracic Surgeons | Asheville | North Carolina | United States | 28803 |
| 115 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 116 | West forest School of Medicine | Winston-Salem | North Carolina | United States | 27157 |
| 117 | Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 118 | Summa Health Systems | Akron | Ohio | United States | 44309 |
| 119 | Good Samaritan Hospital | Cincinnati | Ohio | United States | 45219 |
| 120 | Sterling Research Group | Cincinnati | Ohio | United States | 45219 |
| 121 | Good Samaritan Hospital -Seton Center | Cincinnati | Ohio | United States | 45220 |
| 122 | Tri Health Bethesda North Hospital | Cincinnati | Ohio | United States | 45242 |
| 123 | University Hopital of Cleveland | Cleveland | Ohio | United States | 44106 |
| 124 | Mt. Carmel West | Columbus | Ohio | United States | 43222 |
| 125 | Dayton Heart Center | Dayton | Ohio | United States | 45414 |
| 126 | North Ohio Heart Center | Sandusky | Ohio | United States | 44870 |
| 127 | Oklahoma Foundation for Cardiovascular Research | Oklahoma City | Oklahoma | United States | 73104 |
| 128 | University of Oklahoma | Oklahoma City | Oklahoma | United States | 73104 |
| 129 | Integris Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73112 |
| 130 | Bend Memorial Clinic | Bend | Oregon | United States | 97701 |
| 131 | Northwest Surgical Associates | Portland | Oregon | United States | 97210 |
| 132 | Legacy Good Samaritan Hospital | Portland | Oregon | United States | 97232 |
| 133 | The Heart Center | Doylestown | Pennsylvania | United States | 18901 |
| 134 | North Memorial Pain Institute | Philadelphia | Pennsylvania | United States | 19102 |
| 135 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 136 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 137 | Guthrie Clinical Research | Sayre | Pennsylvania | United States | 18840 |
| 138 | Chester County Cardiovascular Center | West Chester | Pennsylvania | United States | 19380 |
| 139 | The Chattanooga Heart Institute Cardiovascular Group, P.C. | Chattanooga | Tennessee | United States | 37404 |
| 140 | Baptist Memorial Hospital | Memphis | Tennessee | United States | 38120 |
| 141 | Parkway Cardiovascular Associates | Oak Ridge | Tennessee | United States | 37830 |
| 142 | Brackenridge Hospital | Austin | Texas | United States | 78701 |
| 143 | Seton Medical Center | Austin | Texas | United States | 78705 |
| 144 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 145 | Methodist Hospital | Houston | Texas | United States | 77030 |
| 146 | Texas Heart Institute | Houston | Texas | United States | 77030 |
| 147 | VA Medical Center - Houston | Houston | Texas | United States | 77030 |
| 148 | Texas Tech University Health Center | Lubbock | Texas | United States | 79430 |
| 149 | South Texas Cardiovascular Consultants Clinical Research Center | San Antonio | Texas | United States | 78229 |
| 150 | South Texas VA Health Care | San Antonio | Texas | United States | 78284 |
| 151 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78284 |
| 152 | Scott and White Memorial Hospital | Temple | Texas | United States | 76508 |
| 153 | Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
| 154 | Cardiovascular and Thoracic Surgery Associates | Arlington | Virginia | United States | 22205 |
| 155 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22043 |
| 156 | Mary Washington Hospital | Fredericksburg | Virginia | United States | |
| 157 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 158 | Carillion Roanoke Hospital | Roanoke | Virginia | United States | 24014 |
| 159 | VA-Medical Center -Seattle Cardiology | Seattle | Washington | United States | 98108 |
| 160 | University of Washington | Seattle | Washington | United States | 98195 |
| 161 | FHS Research Center | Tacoma | Washington | United States | 98405 |
| 162 | Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 163 | Camcare Health Education & Research Institute | Charleston | West Virginia | United States | 25304 |
| 164 | Appleton Medical Center | Appleton | Wisconsin | United States | 54911 |
| 165 | Gundersen-Lutheran Hospital | La Crosse | Wisconsin | United States | 54601 |
| 166 | Wisconsin Center for Clinical Research | Milwaukee | Wisconsin | United States | 53215 |
| 167 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53295 |
| 168 | Cardiovascular Research and Education Foundation, Inc. | Wausau | Wisconsin | United States | 54401 |
| 169 | Makenzie Health Science Center | Edmonton | Alberta | Canada | T6G 2B7 |
| 170 | Cathy Metcalfe Research Consultants | Delta | British Columbia | Canada | B4K 2G5 |
| 171 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1C6 |
| 172 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 173 | Victoria Heart Institute | Victoria | British Columbia | Canada | V8R 4R2 |
| 174 | University of Manitoba Health Science Centre | Winnipeg | Manitoba | Canada | R2H 2A6 |
| 175 | Health Science Centre | Winnipeg | Manitoba | Canada | R3E 0Z3 |
| 176 | New Brunswick Heart Center | St. John | New Brunswick | Canada | E2L 4L2 |
| 177 | General Hospital Health Science Center | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 178 | Dalhousie University | Halifax | Nova Scotia | Canada | B3H 3A7 |
| 179 | McMaster Clinic | Hamilton | Ontario | Canada | L8L 2X2 |
| 180 | Sunnybrook & Women's College Health Science Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 181 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
| 182 | Montreal Heart Institute | Montreal | Quebec | Canada | H1T 1C8 |
| 183 | University of Montreal | Montreal | Quebec | Canada | H2L 4M1 |
| 184 | Royal Victoria Hospital | Montreal | Quebec | Canada | H3A 1A1 |
| 185 | Hopital Laval | Quebec City | Quebec | Canada | G1V 4G5 |
| 186 | Regina General Hospital | Regina | Saskatchewan | Canada | S4P 0W5 |
Sponsors and Collaborators
- Alexion Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00048308
Other Study ID Numbers:
- 2000099
- PRIMO-CABG
First Posted:
Oct 31, 2002
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Alexion Pharmaceuticals