Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
Information source: The Medicines Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: clevidipine (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: The Medicines Company
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.
Clinical Details
Official title: Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Incidence of bailout during 30-minute treatment period
Secondary outcome: Median time to target SBP lowering effect (defined as a reduction by 15% or more)Mean arterial pressure (MAP) change from baseline Heart rate change from baseline Incidence of bailout by causality
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Discovery Alliance - Mobile Infirmary Medical Center, Mobile, Alabama 36602, United States
Keck School of Medicine, University of Southern California, Los Angeles, California 90033, United States
Huntington Memorial Hospital, Pasadena, California 91109, United States
Stanford University School of Medicine, Stanford, California 94305-5640, United States
Emory Hospital, Atlanta, Georgia 30322, United States
Heart Care Research Foundation, Blue Island, Illinois 60406, United States
MacNeal Hospital, Glencoe, Illinois 60022, United States
Wesley Medical Center, Wichita, Kansas 67214, United States
St. Lukes Hospital, Kansas City, Missouri 64111, United States
International Heart Institute, Missoula, Montana 59802, United States
Columbia University - College of Physicians and Surgeons, New York, New York 10032, United States
Mt. Sinai Medical Center, New York, New York 10029-6574, United States
Carolinas Medical Center, Charlotte, North Carolina 28203, United States
Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion, Houston, Texas 77030, United States
Medical College of Wisconsin VAMC - Milwaukee, Milwaukee, Wisconsin 53295, United States
Additional Information
Starting date: December 2003
Last updated: May 7, 2014
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