Coronary Artery Disease Clinical Trial
Official title:
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)
| Verified date | February 2018 |
| Source | Alexion Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4000 |
| Est. completion date | October 2005 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital Minjoz | Besancon | |
| France | Hopital du Bocage | Dijon | |
| France | Hopital Albert Michallon | Grenoble | |
| France | Hopital Europeen Georges Pompidou | Paris | |
| Germany | Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet | Erlangen | |
| Netherlands | Leiden University Medical Center | Leiden | |
| United States | Akron General Medical Center | Akron | Ohio |
| United States | Virginia Hospital Center | Arlington | Virginia |
| United States | Emory University Hospital | Atlanta | Georgia |
| United States | Piedmont Hospital | Atlanta | Georgia |
| United States | John F. Kennedy Medical Center | Atlantis | Florida |
| United States | Heart Hospital of Austin | Austin | Texas |
| United States | Bakersfield Heart Hospital | Bakersfield | California |
| United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
| United States | Union Memorial Hospital | Baltimore | Maryland |
| United States | St. Charles Medical Center | Bend | Oregon |
| United States | Baptist Health Systems Montclair | Birmingham | Alabama |
| United States | Baptist Medical Center Princeton | Birmingham | Alabama |
| United States | Brookwood Medical Center | Birmingham | Alabama |
| United States | Medical Center East Hospital | Birmingham | Alabama |
| United States | University of Alabama at Birmingham Hospital | Birmingham | Alabama |
| United States | Medcenter One | Bismarck | North Dakota |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | St. Vincent's Medical Center | Bridgeport | Connecticut |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | Maimondes Medical Center | Brooklyn | New York |
| United States | Cooper Health System/University Medical Center | Camden | New Jersey |
| United States | Cooper Hospital University Medical Center | Camden | New Jersey |
| United States | Our Lady Of Lourdes Medical Center | Camden | New Jersey |
| United States | University of North Carolina at Chapel Hill Hospitals | Chapel Hill | North Carolina |
| United States | Charleston Area Medical Center | Charleston | West Virginia |
| United States | Roper St. Francis Healthcare | Charleston | South Carolina |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | The Chattanooga Heart Institute | Chattanooga | Tennessee |
| United States | Bethesda North Hospital | Cincinnati | Ohio |
| United States | Good Samaritan Hospital | Cincinnati | Ohio |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Morton Plant Hospital | Clearwater | Florida |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | University Hospitals Health System | Cleveland | Ohio |
| United States | Riverside Methodist Hospital | Columbus | Ohio |
| United States | Medical City Dallas Hospital | Dallas | Texas |
| United States | Seaton Medical Center | Daly City | California |
| United States | The Dayton Heart Hospital | Dayton | Ohio |
| United States | Halifax Medical Center | Daytona Beach | Florida |
| United States | Atlanta Veteran's Administration (VA) Medical Center | Decatur | Georgia |
| United States | Porter Adventist Hospital | Denver | Colorado |
| United States | Presbyterian St.Luke's Medical Center | Denver | Colorado |
| United States | University of Colorado Health Sciences Center | Denver | Colorado |
| United States | Iowa Heart Center | Des Moines | Iowa |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Doylestown Hospital | Doylestown | Pennsylvania |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Palomar Medical Center | Escondido | California |
| United States | Thomas Hospital | Fairhope | Alabama |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | McLaren Regional Medical Center | Flint | Michigan |
| United States | North Ridge Medical Center | Fort Lauderdale | Florida |
| United States | Sparks Regional Medical Center | Fort Smith | Arkansas |
| United States | Indiana Ohio Heart | Fort Wayne | Indiana |
| United States | Shands Hospital at the University of Florida | Gainesville | Florida |
| United States | Spectrum Health Hospitals | Grand Rapids | Michigan |
| United States | Moses H. Cone Memorial Hospital | Greensboro | North Carolina |
| United States | Pitt County Memorial Hospital | Greenville | North Carolina |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii |
| United States | Terrebonne General Medical Center | Houma | Louisiana |
| United States | Christus Saint Joseph Hospital | Houston | Texas |
| United States | Memorial Hermann Hospital | Houston | Texas |
| United States | Methodist Hospital | Houston | Texas |
| United States | Michael E. DeBakey Veterans Affairs Medical Center | Houston | Texas |
| United States | St. Luke's Episcopal Hospital - Texas Heart | Houston | Texas |
| United States | The Methodist Hospital | Houston | Texas |
| United States | Regional Medical Center Bayonet Point | Hudson | Florida |
| United States | Huntsville Hospital | Huntsville | Alabama |
| United States | Cape Cod Hospital | Hyannis | Massachusetts |
| United States | Clarian Health Partners, Inc. Methodist Hospital | Indianapolis | Indiana |
| United States | The Heart Center of Indiana | Indianapolis | Indiana |
| United States | The Indiana Heart Hospital | Indianapolis | Indiana |
| United States | Jackson-Madison County General Hospital | Jackson | Tennessee |
| United States | Baptist Medical Center | Jacksonville | Florida |
| United States | Memorial Hospital | Jacksonville | Florida |
| United States | United Health Services Hospital | Johnson City | New York |
| United States | Borgess Medical Center | Kalamazoo | Michigan |
| United States | St. Luke's Health System | Kansas City | Missouri |
| United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
| United States | Louisiana Heart Hospital | Lacombe | Louisiana |
| United States | Saddleback Memorial Medical Center | Laguna Hills | California |
| United States | Lakeland Regional Medical Center | Lakeland | Florida |
| United States | St. Mary Medical Center | Langhorne | Pennsylvania |
| United States | Ingham Regional Medical Center | Lansing | Michigan |
| United States | Central Baptist Hospital | Lexington | Kentucky |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Veterans Affairs Medical Center | Lexington | Kentucky |
| United States | Nebraska Heart Hospital | Lincoln | Nebraska |
| United States | Baptist Medical Center | Little Rock | Arkansas |
| United States | Los Angeles County-University of Southern California Medical Center | Los Angeles | California |
| United States | St. Vincent Medical Center | Los Angeles | California |
| United States | University of Southern California University Hospital | Los Angeles | California |
| United States | Veterans Administration Greater Los Angeles Healthcare Sysytem | Los Angeles | California |
| United States | Jewish Hospital | Louisville | Kentucky |
| United States | Norton Hospital | Louisville | Kentucky |
| United States | University of Louisville Hospital | Louisville | Kentucky |
| United States | Covenant Medical Center | Lubbock | Texas |
| United States | Medical Center of Central Georgia | Macon | Georgia |
| United States | Memorial Regional Medical Center | Mechanicsville | Virginia |
| United States | Health First Holmes Regional Medical Center | Melbourne | Florida |
| United States | Baptist Memorial Hospital | Memphis | Tennessee |
| United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
| United States | Mobile Infirmary Medical Center | Mobile | Alabama |
| United States | Morristown Memorial Hospital | Morristown | New Jersey |
| United States | West Shore Cardiology Research Department | Muskegon | Michigan |
| United States | Baptist Hospital | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Hospital of Saint Raphael | New Haven | Connecticut |
| United States | Oschner Clinic Foundation | New Orleans | Louisiana |
| United States | Pendleton Memorial Methodist Hospital | New Orleans | Louisiana |
| United States | Touro Infirmary | New Orleans | Louisiana |
| United States | Tulane University Hospital and Clinic | New Orleans | Louisiana |
| United States | Mount Sinai Hospital | New York | New York |
| United States | New York Presbyterian Hospital | New York | New York |
| United States | Christiana Hospital | Newark | Delaware |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Methodist Medical Center | Oak Ridge | Tennessee |
| United States | Tri City Medical Center | Oceanside | California |
| United States | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma |
| United States | Oklahoma Heart Hospital | Oklahoma City | Oklahoma |
| United States | Oklahoma University Medical Center | Oklahoma City | Oklahoma |
| United States | Olathe Medical Center | Olathe | Kansas |
| United States | University of California Irvine Medical Center | Orange | California |
| United States | Florida Hospital | Orlando | Florida |
| United States | Orlando Regional Medical Center | Orlando | Florida |
| United States | Veterans Administration Palo Alto Healthcare System | Palo Alto | California |
| United States | Huntington Memorial Hospital | Pasadena | California |
| United States | Sacred Heart Hospital | Pensacola | Florida |
| United States | OSF Saint Francis Medical Center | Peoria | Illinois |
| United States | Hahnemann University Hospital | Philadelphia | Pennsylvania |
| United States | Presbyterian Medical Center | Philadelphia | Pennsylvania |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | Banner Good Samaritan Medical Center | Phoenix | Arizona |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Legacy Good Samaritan Hospital | Portland | Oregon |
| United States | Maine Medical Center | Portland | Maine |
| United States | Vassar Brothers Medical Center | Poughkeepsie | New York |
| United States | Rapid City Regional Hospital | Rapid City | South Dakota |
| United States | CJW Medical Center | Richmond | Virginia |
| United States | Henrico Doctors' Hospital | Richmond | Virginia |
| United States | Mayo Clinic College of Medicine | Rochester | Minnesota |
| United States | Rochester General Hospital | Rochester | New York |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | Wuesthoff Hospital | Rockledge | Florida |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | Mercy General Hospital | Sacramento | California |
| United States | Covenant Medical Center | Saginaw | Michigan |
| United States | Des Peres Hospital | Saint Louis | Missouri |
| United States | Saint Louis University | Saint Louis | Missouri |
| United States | Saint Louis University Hospital | Saint Louis | Missouri |
| United States | Northside Hospital and Heart Institute | Saint Petersburg | Florida |
| United States | Peninusla Medical Center | Salisbury | Maryland |
| United States | University of Utah Hospital | Salt Lake City | Utah |
| United States | Northeast Baptist Hospital | San Antonio | Texas |
| United States | TexSan Heart Hospital | San Antonio | Texas |
| United States | Sharp Memorial Hospital | San Diego | California |
| United States | Kaiser Permanente Medical Center | San Francisco | California |
| United States | Sarasota Memorial Hospital | Sarasota | Florida |
| United States | St. Joseph's/Candler Health System | Savannah | Georgia |
| United States | St. Joseph's/Candler Health System | Savannah | Georgia |
| United States | University of Washington Medical Center | Seattle | Washington |
| United States | Slidell Memorial Hospital | Slidell | Louisiana |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | Memorial Medical Center | Springfield | Illinois |
| United States | St. John's Hospital | Springfield | Illinois |
| United States | Saint Joseph Medical Center | Tacoma | Washington |
| United States | University Community Hospital | Tampa | Florida |
| United States | The Toledo Hospital | Toledo | Ohio |
| United States | St. Joseph Medical Center | Towson | Maryland |
| United States | Arizona Health Sciences Center | Tucson | Arizona |
| United States | Southern Arizona Veterans Affairs Health Care System | Tucson | Arizona |
| United States | University Medical Center | Tucson | Arizona |
| United States | Crozer Chester Medical Center | Upland | Pennsylvania |
| United States | Westchester Medical Center | Valhalla | New York |
| United States | The Chester County Hospital | West Chester | Pennsylvania |
| United States | Veterans Administration (VA) Boston Healthcare System | West Roxbury | Massachusetts |
| United States | Galichia Heart Hospital | Wichita | Kansas |
| United States | Good Samaritan Hospital | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Alexion Pharmaceuticals | Procter and Gamble |
United States, France, Germany, Netherlands,
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|---|---|---|---|---|
| Primary | Reduction in mortality. | |||
| Primary | Reduction in MI incidence. |
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