Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093912
First received: October 7, 2004
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: clevidipine
Drug: sodium nitroprusside
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Incidence of death, stroke, MI and renal dysfunction [ Time Frame: Initiation of study drug infusion through post-operative Day 30 ] [ Designated as safety issue: No ]

Enrollment: 739
Study Start Date: June 2004
Study Completion Date: November 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: sodium nitroprusside
Sodium nitroprusside (SNP) 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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093912

  Show 29 Study Locations
Sponsors and Collaborators
The Medicines Company
Investigators
Study Director: Malcolm Lloyd, MD The Medicines Company - Medical Director, Clinical Operations
  More Information

Publications:
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00093912     History of Changes
Other Study ID Numbers: TMC-CLV-03-04, ECLIPSE-SNP
Study First Received: October 7, 2004
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Perioperative Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nitroprusside
Clevidipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 22, 2014