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

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ClinicalTrials.gov Identifier: NCT00093262
Recruitment Status : Completed
First Posted : October 7, 2004
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: clevidipine Drug: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
Study Start Date : December 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Clevidipine

Arms and Interventions
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Arm Intervention/treatment
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 Name: clevidipine, Cleviprex
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. Mean arterial pressure (MAP) change from baseline [ Time Frame: During the first 30 minutes post study drug initiation ]
  3. Heart rate change from baseline [ Time Frame: During the first 30 minutes post study drug initiation ]
  4. Incidence of bailout by causality [ Time Frame: During the first 30 minutes post study drug initiation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093262


Locations
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United States, Alabama
Discovery Alliance - Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36602
United States, California
Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90033
Huntington Memorial Hospital
Pasadena, California, United States, 91109
Stanford University School of Medicine
Stanford, California, United States, 94305-5640
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Heart Care Research Foundation
Blue Island, Illinois, United States, 60406
MacNeal Hospital
Glencoe, Illinois, United States, 60022
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Missouri
St. Lukes Hospital
Kansas City, Missouri, United States, 64111
United States, Montana
International Heart Institute
Missoula, Montana, United States, 59802
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029-6574
Columbia University - College of Physicians and Surgeons
New York, New York, United States, 10032
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Texas
Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin VAMC - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
The Medicines Company
More Information
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Publications of Results:

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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00093262    
Other Study ID Numbers: TMC-CLV-03-02
ESCAPE-2
First Posted: October 7, 2004    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014
Keywords provided by The Medicines Company:
Postoperative Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Clevidipine
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs