The purpose of this study is to establish the safety of clevidipine in the treatment of
perioperative hypertension. Approximately 500-900 patients with perioperative hypertension
undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB)
or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve
replacement/repair procedures were anticipated to be randomly assigned to one of two
treatment groups: clevidipine or nitroglycerin.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Prerandomization Inclusion Criteria:
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age
- Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery
Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery,
and/or valve replacement/repair surgery
Prerandomization Exclusion Criteria:
- Women of child-bearing potential (unless they have a negative pregnancy test)
- Recent cerebrovascular accident (within 3 months before randomization)
- Known intolerance to calcium channel blockers
- Known or suspected hypersensitivity to nitroglycerin
- Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
- Pre-existing permanent ventricular pacing
- Any other disease or condition, which, in the judgment of the investigator would
place a patient at undue risk by being enrolled in the trial
- Participation in another therapeutic drug or therapeutic device trial within 30 days
of starting study
Postrandomization Inclusion Criteria:
- Determined to be hypertensive perioperatively as determined by the investigator
Baptist Medical Center, Montclair, Birmingham, Alabama 35213, United States
Brookwood Medical Center, Birmingham, Alabama 35209, United States
Medical Center East, Birmingham, Alabama 35235, United States
Baptist Medical Center, South, Montgomery, Alabama 36116, United States
University Medical Center, Tucson, Arizona 85724, United States
Saddleback Memorial Medical Center, Laguna Hills, California 92653, United States
Keck School of Medicine, University of Southern California, Los Angeles, California 90033, United States
Huntington Memorial Hospital, Pasadena, California 91109, United States
University of California, San Francisco, California 94143-0648, United States
Regional Medical Center - Bayonet Point, Hudson, Florida 34667, United States
Health First Holmes Regional Medical Center, Melbourne, Florida 32901, United States
Sacred Heart Health System, Pensacola, Florida 32504, United States
Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii 96817, United States
Saint Francis Hospital, Evanston, Illinois 60202, United States
Wesley Medical Center, Wichita, Kansas 67214, United States
St Joseph Medical Center, Towson, Maryland 21204, United States
Henry Ford Health System, Detroit, Michigan 48202, United States
New York University Medical Center, New York, New York 10016, United States
Sterling Research Group, Ltd., Cincinnati, Ohio 45219, United States
The Christ Hospital, The Linder Clinical Trial Center, Cincinnati, Ohio 45219, United States
Portland VA Medical Center, Portland, Oregon 97239, United States
Houston Northwest Medical Center, Houston, Texas 77090, United States
Memorial Herman Memorial City Hospital, Houston, Texas 77024, United States
Michael E DeBakey VA Medical Center, Houston, Texas 77030-4211, United States
The Methodist Hospital, Houston, Texas 77030, United States
Inova Fairfax Hospital, Falls Church, Virginia 22042, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia 23298, United States
Saint Joseph Medical Center, Tacoma, Washington 98405, United States