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

May 5, 2014 updated by: The Medicines Company

Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

739

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Brookwood Medical Center
      • Birmingham, Alabama, United States, 35205
        • Saint Vincents Hospital
      • Birmingham, Alabama, United States, 35213
        • Baptist Medical Center, Montclair
      • Montgomery, Alabama, United States, 36106
        • Drug Research and Analysis Corporation
      • Montgomery, Alabama, United States, 36101
        • Baptist Medical Center, South
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital at the University of Florida
      • Melbourne, Florida, United States, 32901
        • Health First Holmes Regional Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Kaiser Permanente
    • Illinois
      • Blue Island, Illinois, United States, 60406
        • St. Francis Hospital and Health Center
      • Evanston, Illinois, United States, 60202
        • St. Francis Hospital of Evanston
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70115
        • Touro Infirmary
    • Maryland
      • Towson, Maryland, United States, 21204
        • St. Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachussettes General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Saint Lukes Hospital
    • Montana
      • Missoula, Montana, United States, 59802
        • International Heart Institute/St. Patrick Hospital
    • New York
      • New York, New York, United States, 10029-6574
        • Mt. Sinai Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson-Madison County General Hospital
    • Texas
      • Houston, Texas, United States, 77090
        • Houston Northwest Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • LDS Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Medical College of Wisconsin VAMC - Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of death, stroke, MI and renal dysfunction
Time Frame: Initiation of study drug infusion through post-operative Day 30
Initiation of study drug infusion through post-operative Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Medicines Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

October 7, 2004

First Submitted That Met QC Criteria

October 7, 2004

First Posted (ESTIMATE)

October 8, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMC-CLV-03-04
  • ECLIPSE-SNP (OTHER: Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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