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

  Hide Study Locations
Locations
United States, Alabama
Brookwood Medical Center
Birmingham, Alabama, United States, 35209
Baptist Medical Center, Montclair
Birmingham, Alabama, United States, 35213
Saint Vincents Hospital
Birmingham, Alabama, United States, 35205
Baptist Medical Center, South
Montgomery, Alabama, United States, 36101
Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36106
United States, California
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
United States, Hawaii
Kaiser Permanente
Honolulu, Hawaii, United States, 96817
United States, Illinois
St. Francis Hospital and Health Center
Blue Island, Illinois, United States, 60406
St. Francis Hospital of Evanston
Evanston, Illinois, United States, 60202
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, Maryland
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Massachussettes General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Saint Lukes Hospital
Duluth, Minnesota, United States, 55805
United States, Montana
International Heart Institute/St. Patrick Hospital
Missoula, Montana, United States, 59802
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029-6574
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
United States, Texas
Houston Northwest Medical Center
Houston, Texas, United States, 77090
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin VAMC - Milwaukee
Milwaukee, Wisconsin, United States, 53295
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
Cardiovascular Diseases
Vascular Diseases
Clevidipine
Nitroprusside
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014