Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)
ECLIPSE-NIC
Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)
2 other identifiers
interventional
739
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started May 2004
Typical duration for phase_3 hypertension
9 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
May 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
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMay 6, 2014
May 1, 2014
2.2 years
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 postoperative 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.
nicardipine
ACTIVE COMPARATORNicardipine (NIC) was initiated after insertion of an arterial line upon the occurrence of postoperative 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 nicardipine
- 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
- Expected to survive beyond 24 hours post-surgical procedure
- Determined to be hypertensive postoperatively as determined by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Touro Infirmary
New Orleans, Louisiana, 70115, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Columbia University - College of Physicians and Surgeons
New York, New York, 10032, United States
Jack D. Weller Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
VA Medical Center McGuire
Richmond, Virginia, 23249, 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
May 1, 2004
Primary Completion
July 1, 2006
Study Completion
September 1, 2006
Last Updated
May 6, 2014
Record last verified: 2014-05