The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after 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 nicardipine.
The primary objective was to establish the safety of clevidipine in the treatment of postoperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nicardipine treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
739
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Wesley Medical Center
Wichita, Kansas, United States
Touro Infirmary
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
Incidence of death, stroke, MI, and renal dysfunction
Time frame: Initiation of study drug infusion through post-operative Day 30
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New Orleans, Louisiana, United States
Columbia University - College of Physicians and Surgeons
New York, New York, United States
Jack D. Weller Hospital
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
VA Medical Center McGuire
Richmond, Virginia, United States