Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
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.
The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nitroglycerin 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.
Prerandomization Inclusion Criteria:
Prerandomization Exclusion Criteria:
Postrandomization Inclusion Criteria:
Los Angeles, California 90033, United States