Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)
ECLIPSE-NTG
Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
1 other identifier
interventional
629
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Apr 2004
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2004
CompletedFirst Posted
Study publicly available on registry
October 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedMay 6, 2014
May 1, 2014
11 months
October 7, 2004
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of death, stroke, MI and renal dysfunction
Initiation of study drug infusion through post-operative Day 30
Study Arms (2)
clevidipine
EXPERIMENTALClevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above 3.2 μg/kg/min were permitted up to the maximum infusion rate of 8.0 μg/kg/min. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Infusion rates between 4.4 and 8.0 μg/kg/min were to be administered for no more than 2 hours.
nitroglycerin
ACTIVE COMPARATORNitroglycerin (NTG) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Determined to be hypertensive perioperatively as determined by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Brookwood Medical Center
Birmingham, Alabama, 35209, United States
Baptist Medical Center, Montclair
Birmingham, Alabama, 35213, 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
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
Houston Northwest Medical Center
Houston, Texas, 77090, 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
Related Publications (1)
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.
PMID: 18806012RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Malcolm Lloyd, MD
The Medicines Company - Medical Director, Clinical Operations
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2004
First Posted
October 8, 2004
Study Start
April 1, 2004
Primary Completion
March 1, 2005
Study Completion
April 1, 2005
Last Updated
May 6, 2014
Record last verified: 2014-05