Clinical trial NCT00093912: Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)
Official title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Perioperative Hypertension
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2004-10-08
Enrollment: 739
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 250-500 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 sodium nitroprusside.

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 sodium nitroprusside 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 sodium nitroprusside
* 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: Saint Vincents Hospital
state: Alabama
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Baptist Medical Center, Montclair
state: Alabama
city: Montgomery
country: United States
facility: Baptist Medical Center, South
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corporation
state: Alabama
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Melbourne
country: United States
facility: Health First Holmes Regional Medical Center
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente
state: Hawaii
city: Blue Island
country: United States
facility: St. Francis Hospital and Health Center
state: Illinois
city: Evanston
country: United States
facility: St. Francis Hospital of Evanston
state: Illinois
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Touro Infirmary
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachussettes General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Duluth
country: United States
facility: Saint Lukes Hospital
state: Minnesota
city: Missoula
country: United States
facility: International Heart Institute/St. Patrick Hospital
state: Montana
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Houston
country: United States
facility: Houston Northwest Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin VAMC - Milwaukee
state: Wisconsin
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.