Coronary Artery DiseasePhase 3NCT00088179
Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
A Phase 3 study testing pexelizumab in conjunction with CABG in people with Coronary Artery Disease, run by Alexion Pharmaceuticals, Inc. at 188 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- pexelizumab in conjunction with CABG
- How many people
- 4,000 participants
- Where
- 188 sitesin 4 countries
- Study dates
- Jul 2004to Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
188 sites in 4 countries.
188 sites in 4 countries
United States182 sites
Akron General Medical Center
Akron, Ohio, 44307
Virginia Hospital Center
Arlington, Virginia, 22205
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
John F. Kennedy Medical Center
Atlantis, Florida, 33462
Heart Hospital of Austin
Austin, Texas, 78756
Bakersfield Heart Hospital
Bakersfield, California, 93301
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Union Memorial Hospital
Baltimore, Maryland, 21218
St. Charles Medical Center
Bend, Oregon, 97701
Brookwood Medical Center
Birmingham, Alabama, 35209
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Baptist Health Systems Montclair
Birmingham, Alabama, 35213
Medical Center East Hospital
Birmingham, Alabama, 35235
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249-6810
Medcenter One
Bismarck, North Dakota, 58501
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606
Maimondes Medical Center
Brooklyn, New York, 11219
Cooper Hospital University Medical Center
Camden, New Jersey, 08035
Cooper Health System/University Medical Center
Camden, New Jersey, 08103
Our Lady Of Lourdes Medical Center
Camden, New Jersey, 08103
University of North Carolina at Chapel Hill Hospitals
Chapel Hill, North Carolina, 27599-7075
Roper St. Francis Healthcare
Charleston, South Carolina, 29401
Charleston Area Medical Center
Charleston, West Virginia, 25304
University of Virginia Health System
Charlottesville, Virginia, 22908
The Chattanooga Heart Institute
Chattanooga, Tennessee, 37404
The Christ Hospital
Cincinnati, Ohio, 45219
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0542
Morton Plant Hospital
Clearwater, Florida, 33756
University Hospitals Health System
Cleveland, Ohio, 44106-5011
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Riverside Methodist Hospital
Columbus, Ohio, 43214
Medical City Dallas Hospital
Dallas, Texas, 75230
Seaton Medical Center
Daly City, California, 94015
The Dayton Heart Hospital
Dayton, Ohio, 45408
Halifax Medical Center
Daytona Beach, Florida, 32114
Atlanta Veteran's Administration (VA) Medical Center
Decatur, Georgia, 30033
Porter Adventist Hospital
Denver, Colorado, 80210
Presbyterian St.Luke's Medical Center
Denver, Colorado, 80218
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Iowa Heart Center
Des Moines, Iowa, 50314
Henry Ford Health System
Detroit, Michigan, 48202
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Duke University Medical Center
Durham, North Carolina, 27710
Palomar Medical Center
Escondido, California, 92025
Thomas Hospital
Fairhope, Alabama, 36532
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
McLaren Regional Medical Center
Flint, Michigan, 48532
North Ridge Medical Center
Fort Lauderdale, Florida, 33334
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Indiana Ohio Heart
Fort Wayne, Indiana, 46804
Shands Hospital at the University of Florida
Gainesville, Florida, 32610
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
Pitt County Memorial Hospital
Greenville, North Carolina, 27858
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Terrebonne General Medical Center
Houma, Louisiana, 70360
Christus Saint Joseph Hospital
Houston, Texas, 77002
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030-4298
Memorial Hermann Hospital
Houston, Texas, 77030
Methodist Hospital
Houston, Texas, 77030
St. Luke's Episcopal Hospital - Texas Heart
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Regional Medical Center Bayonet Point
Hudson, Florida, 34667
Huntsville Hospital
Huntsville, Alabama, 35801
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Clarian Health Partners, Inc. Methodist Hospital
Indianapolis, Indiana, 46202
The Indiana Heart Hospital
Indianapolis, Indiana, 46250
The Heart Center of Indiana
Indianapolis, Indiana, 46290
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
Baptist Medical Center
Jacksonville, Florida, 32207
Memorial Hospital
Jacksonville, Florida, 32216
United Health Services Hospital
Johnson City, New York, 13790
Borgess Medical Center
Kalamazoo, Michigan, 49048
St. Luke's Health System
Kansas City, Missouri, 64111
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Louisiana Heart Hospital
Lacombe, Louisiana, 70445
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Lakeland Regional Medical Center
Lakeland, Florida, 33805
St. Mary Medical Center
Langhorne, Pennsylvania, 19067
Ingham Regional Medical Center
Lansing, Michigan, 48910
Central Baptist Hospital
Lexington, Kentucky, 40503
Veterans Affairs Medical Center
Lexington, Kentucky, 40506
University of Kentucky
Lexington, Kentucky, 40536
Nebraska Heart Hospital
Lincoln, Nebraska, 68506
Baptist Medical Center
Little Rock, Arkansas, 72205
Los Angeles County-University of Southern California Medical Center
Los Angeles, California, 90033
University of Southern California University Hospital
Los Angeles, California, 90033
St. Vincent Medical Center
Los Angeles, California, 90057
Veterans Administration Greater Los Angeles Healthcare Sysytem
Los Angeles, California, 90073
Jewish Hospital
Louisville, Kentucky, 40202
Norton Hospital
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
Covenant Medical Center
Lubbock, Texas, 79410
Medical Center of Central Georgia
Macon, Georgia, 31208
Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901
Baptist Memorial Hospital
Memphis, Tennessee, 38120
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
West Shore Cardiology Research Department
Muskegon, Michigan, 46444
Baptist Hospital
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8815
Hospital of Saint Raphael
New Haven, Connecticut, 06511
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Oschner Clinic Foundation
New Orleans, Louisiana, 70121
Pendleton Memorial Methodist Hospital
New Orleans, Louisiana, 70127
Touro Infirmary
New Orleans, Louisiana
New York Presbyterian Hospital
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Christiana Hospital
Newark, Delaware, 19718
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Methodist Medical Center
Oak Ridge, Tennessee, 37830
Tri City Medical Center
Oceanside, California, 92056
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Olathe Medical Center
Olathe, Kansas, 66061
University of California Irvine Medical Center
Orange, California, 92868
Orlando Regional Medical Center
Orlando, Florida, 32801
Florida Hospital
Orlando, Florida, 32803
Veterans Administration Palo Alto Healthcare System
Palo Alto, California, 94304
Huntington Memorial Hospital
Pasadena, California, 91105
Sacred Heart Hospital
Pensacola, Florida, 32504
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Maine Medical Center
Portland, Maine, 04102
Legacy Good Samaritan Hospital
Portland, Oregon, 97210
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
CJW Medical Center
Richmond, Virginia, 23225
Henrico Doctors' Hospital
Richmond, Virginia, 23229
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York, 14621
University of Rochester Medical Center
Rochester, New York, 14642
Wuesthoff Hospital
Rockledge, Florida, 32955
William Beaumont Hospital
Royal Oak, Michigan, 48073
Mercy General Hospital
Sacramento, California, 95819
Covenant Medical Center
Saginaw, Michigan, 48601
Peninusla Medical Center
Salisbury, Maryland, 21801
University of Utah Hospital
Salt Lake City, Utah, 84132
TexSan Heart Hospital
San Antonio, Texas, 78201
Northeast Baptist Hospital
San Antonio, Texas, 78217
Sharp Memorial Hospital
San Diego, California, 92123
Kaiser Permanente Medical Center
San Francisco, California, 94115
Sarasota Memorial Hospital
Sarasota, Florida, 34239
St. Joseph's/Candler Health System
Savannah, Georgia, 31404
St. Joseph's/Candler Health System
Savannah, Georgia, 31419
University of Washington Medical Center
Seattle, Washington, 98195-6310
Slidell Memorial Hospital
Slidell, Louisiana, 70458
Memorial Medical Center
Springfield, Illinois, 62702
St. John's Hospital
Springfield, Illinois, 62769
Baystate Medical Center
Springfield, Massachusetts, 01199
Saint Louis University Hospital
St Louis, Missouri, 63110
Saint Louis University
St Louis, Missouri, 63110
Des Peres Hospital
St Louis, Missouri, 63122
Northside Hospital and Heart Institute
St. Petersburg, Florida, 33701
Saint Joseph Medical Center
Tacoma, Washington, 98405
University Community Hospital
Tampa, Florida, 33613
Montefiore Medical Center
The Bronx, New York, 10461
The Toledo Hospital
Toledo, Ohio, 43606
St. Joseph Medical Center
Towson, Maryland, 21204
Arizona Health Sciences Center
Tucson, Arizona, 85724
University Medical Center
Tucson, Arizona, 85724
Southern Arizona Veterans Affairs Health Care System
Tucson, Arizona, 85732
Crozer Chester Medical Center
Upland, Pennsylvania, 19013
Westchester Medical Center
Valhalla, New York, 10595
The Chester County Hospital
West Chester, Pennsylvania, 19380
Veterans Administration (VA) Boston Healthcare System
West Roxbury, Massachusetts, 02132
Galichia Heart Hospital
Wichita, Kansas, 67202
Good Samaritan Hospital
Zanesville, Ohio, 43701
France4 sites
Hopital Minjoz
Besançon, 25030
Hopital du Bocage
Dijon, 21031
Hopital Albert Michallon
Grenoble, 38043
Hopital Europeen Georges Pompidou
Paris, 75908
Germany1 site
Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet
Erlangen, 91054
About this study
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)
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.
- Conditions
- Coronary Artery Disease
- Being tested
- pexelizumab in conjunction with CABG
- Keywords
- CABG, CPB
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pexelizumab in conjunction with CABGDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mortality.
Reduction in MI incidence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2004 (estimated)
- Study startJul 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 4,000 participants
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Investigators
- Peter X Adams, MD, Study director, Alexion Pharmaceuticals, Inc.Edward Verrier, MD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088179
- Sponsor's protocol ID
- 2003141
- Status last verified
- Feb 2018
- First submitted
- 21 Jul 2004
- Last updated
- 22 Feb 2018
- Results posted
- No
Publications
Smith PK, Shernan SK, Chen JC, Carrier M, Verrier ED, Adams PX, Todaro TG, Muhlbaier LH, Levy JH; PRIMO-CABG II Investigators. Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: combined results from the PRIMO-CABG I and II trials. J Thorac Cardiovasc Surg. 2011 Jul;142(1):89-98. doi: 10.1016/j.jtcvs.2010.08.035. Epub 2010 Sep 28.
PubMed 20880552
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00088179
- Acronym / sponsor ID
- 2003141
- Conditions
- Coronary Artery Disease
- Keywords
- CABG, CPB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Jul 2004 (actual)
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 23 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be at least 18 years of age;
- have 2 or more of the following risk factors:
- provide Informed Consent.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pexelizumab in conjunction with CABG | Drug | – |
Primary outcome
Reduction in mortality.
Reduction in MI incidence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 20880552Smith PK, Shernan SK, Chen JC, Carrier M, Verrier ED, Adams PX, Todaro TG, Muhlbaier LH, Levy JH; PRIMO-CABG II Investigators. Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: combined results from the PRIMO-CABG I and II trials. J Thorac Cardiovasc Surg. 2011 Jul;142(1):89-98. doi: 10.1016/j.jtcvs.2010.08.035. Epub 2010 Sep 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter X Adams, MD study director
Alexion Pharmaceuticals, Inc.
Edward Verrier, MD study chair
University of Washington
188 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pexelizumab in conjunction with CABG in people with Coronary Artery Disease, run by Alexion Pharmaceuticals, Inc. at 188 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 188 sites in United States, France, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in mortality.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.