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

• ClinicalTrials.gov Identifier: NCT00093912
• Recruitment Status: Completed
• First Posted: October 8, 2004
• Last Update Posted: May 6, 2014
• Sponsor: The Medicines Company
• Information provided by (Responsible Party): The Medicines Company

Tracking Information

• First Submitted Date: October 7, 2004
• First Posted Date: October 8, 2004
• Last Update Posted Date: May 6, 2014
• Study Start Date: June 2004
• Actual Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 5, 2014): Incidence of death, stroke, MI and renal dysfunction [ Time Frame: Initiation of study drug infusion through post-operative Day 30 ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)
• Official Title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Drug: clevidipine
  Other Name: clevidipine, Cleviprex
• Drug: sodium nitroprusside

Study Arms

• 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.
  Intervention: Drug: clevidipine
• 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.
  Intervention: Drug: sodium nitroprusside

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2014): 739
• Original Enrollment (submitted: June 23, 2005): 500
• Actual Study Completion Date: November 2006
• Actual Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00093912
• Other Study ID Numbers: TMC-CLV-03-04; ECLIPSE-SNP ( Other Identifier: Sponsor )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: The Medicines Company
• Original Responsible Party: Not Provided
• Current Study Sponsor: The Medicines Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Malcolm Lloyd, MD; The Medicines Company - Medical Director, Clinical Operations

• PRS Account: The Medicines Company
• Verification Date: May 2014