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Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG) (ECLIPSE-NTG)

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ClinicalTrials.gov Identifier: NCT00093886
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 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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
Study Start Date : April 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : April 2005

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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 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.
 Drug: clevidipine
Other Name: clevidipine, Cleviprex
Active Comparator: nitroglycerin
Nitroglycerin (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.
 Drug: nitroglycerin


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 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
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): NCT00093886


Locations
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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: NCT00093886    
Other Study ID Numbers: TMC-CLV-03-03
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by The Medicines Company:
Preoperative hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Clevidipine
Nitroglycerin
Vasodilator Agents
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs