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Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC) (ECLIPSE-NIC)

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ClinicalTrials.gov Identifier: NCT00093925
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: clevidipine Drug: nicardipine Phase 3

Detailed Description:
The primary objective was to establish the safety of clevidipine in the treatment of postoperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nicardipine 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 739 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)
Study Start Date : May 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: clevidipine
Clevidipine (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.
 Drug: clevidipine
Other Name: clevidipine, Cleviprex
Active Comparator: nicardipine
Nicardipine (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.
 Drug: nicardipine


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of death, stroke, MI, and renal dysfunction [ Time Frame: Initiation of study drug infusion through post-operative Day 30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Postrandomization Inclusion Criteria:

  • Expected to survive beyond 24 hours post-surgical procedure
  • No surgical complications or conditions, present or anticipated, that preclude them from inclusion in the study
  • Determined to be hypertensive postoperatively as determined by the investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093925


Locations
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United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Touro Infirmary
New Orleans, Louisiana, United States, 70115
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Jack D. Weller Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467
Columbia University - College of Physicians and Surgeons
New York, New York, United States, 10032
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
VA Medical Center McGuire
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
The Medicines Company
Investigators
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Study Director: Malcolm Lloyd, MD The Medicines Company - Medical Director, Clinical Operations
More Information
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Publications of Results:

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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00093925    
Other Study ID Numbers: TMC-CLV-03-05
ECLIPSE-NIC ( Other Identifier: Sponsor )
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by The Medicines Company:
Postoperative hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Nicardipine
Clevidipine
Antihypertensive Agents
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents