Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2) (ESCAPE-2)

May 7, 2014 updated by: The Medicines Company

Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative 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 placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment groups during the 30-minute time period from initiation of study drug. Secondary objectives included assessments of efficacy through measuring time to target blood pressure (BP) lowering effect defined as 15% reduction in SBP, change in mean arterial pressure (MAP) and the incidence of bailout by causality. Assessments for safety included change in heart rate (HR) from baseline.

Study Type

Interventional

Enrollment (Actual)

206

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
      • Mobile, Alabama, United States, 36602
        • Discovery Alliance - Mobile Infirmary Medical Center
    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine, University of Southern California
      • Pasadena, California, United States, 91109
        • Huntington Memorial Hospital
      • Stanford, California, United States, 94305-5640
        • Stanford University School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Hospital
    • Illinois
      • Blue Island, Illinois, United States, 60406
        • Heart Care Research Foundation
      • Glencoe, Illinois, United States, 60022
        • MacNeal Hospital
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Lukes Hospital
    • Montana
      • Missoula, Montana, United States, 59802
        • International Heart Institute
    • New York
      • New York, New York, United States, 10029-6574
        • Mt. Sinai Medical Center
      • New York, New York, United States, 10032
        • Columbia University - College of Physicians and Surgeons
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion
    • 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

Pre-randomization Inclusion Criteria:

  • Provide written informed consent before initiation of any study-related procedures.
  • Be at least 18 years of age
  • Be scheduled for cardiac surgery (including Coronary Artery Bypass Grafting [CABG], Off Pump Coronary Artery Bypass [OPCAB], Minimally Invasive Direct Coronary Artery Bypass [MIDCAB] surgery, and/or valve replacement/repair procedures)

Pre-randomization 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
  • Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
  • Pre-existing left bundle branch block or 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

Post-randomization Inclusion Criteria:

  • Expected to survive beyond 24 hours post-surgical procedure
  • No surgical complications or conditions, present or anticipated, that preclude them from inclusion in a double blind, placebo-controlled study
  • Determined to be hypertensive (SBP > 140 mm Hg) within 4 hours of arrival in a postoperative setting
  • It is the investigator's intent to lower the patient's SBP by a minimum of 15% from its baseline value

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Placebo consisted of 20% lipid emulsion (the same lipid vehicle used for clevidipine) administered in a blinded fashion intravenously following the same study drug administration guidelines as with clevidipine study drug administration guidelines. As with clevidipine, placebo was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.
Drug: placebo
Experimental: clevidipine
Clevidipine was administered in a blinded fashion intravenously, starting with an infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/hr), titrating upward, as tolerated by the patient, in doubling increments approximately every 90 seconds up to an infusion rate of 3.2 μg/kg/min (16 mg/hr) to achieve the desired blood pressure-lowering effect. Up-titration to infusion rates above 3.2 μg/kg/min could be used, guided by the patient's response, by increasing the infusion rate in serial increments of 1.5 μg/kg/min, up to the maximum recommended clevidipine infusion rate of 8.0 μg/kg/min. Clevidipine was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.
Drug: clevidipine
Other Names:
  • clevidipine, Cleviprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bailout during 30-minute treatment period
Time Frame: During the first 30 minutes post study drug initiation

The incidence of bailout defined as the premature and permanent discontinuation of study drug categorized according to the following reasons:

  • Bailout for lack of efficacy
  • Bailout for safety reason(s)
  • Bailout due to treatment failure
During the first 30 minutes post study drug initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Median time to target SBP lowering effect (defined as a reduction by 15% or more)
Time Frame: During the first 30 minutes post study drug initiation
During the first 30 minutes post study drug initiation
Mean arterial pressure (MAP) change from baseline
Time Frame: During the first 30 minutes post study drug initiation
During the first 30 minutes post study drug initiation
Heart rate change from baseline
Time Frame: During the first 30 minutes post study drug initiation
During the first 30 minutes post study drug initiation
Incidence of bailout by causality
Time Frame: During the first 30 minutes post study drug initiation
During the first 30 minutes post study drug initiation

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

December 1, 2003

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

October 5, 2004

First Submitted That Met QC Criteria

October 6, 2004

First Posted (Estimate)

October 7, 2004

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMC-CLV-03-02
  • ESCAPE-2

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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