Clinical trial NCT00093886: Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)
Official title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Preoperative hypertension
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2004-10-08
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of death, stroke, MI and renal dysfunction
timeFrame: Initiation of study drug infusion through post-operative Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Baptist Medical Center, Montclair
state: Alabama
city: Birmingham
country: United States
facility: Medical Center East
state: Alabama
city: Montgomery
country: United States
facility: Baptist Medical Center, South
state: Alabama
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine, University of Southern California
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Hudson
country: United States
facility: Regional Medical Center - Bayonet Point
state: Florida
city: Melbourne
country: United States
facility: Health First Holmes Regional Medical Center
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Health System
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Evanston
country: United States
facility: Saint Francis Hospital
state: Illinois
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Towson
country: United States
facility: St Joseph Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital, The Linder Clinical Trial Center
state: Ohio
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Houston
country: United States
facility: Memorial Herman Memorial City Hospital
state: Texas
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Houston Northwest Medical Center
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Tacoma
country: United States
facility: Saint Joseph Medical Center
state: Washington
Study officials:
affiliation: The Medicines Company - Medical Director, Clinical Operations
name: Malcolm Lloyd, MD
role: STUDY_DIRECTOR
References:
citation: Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.