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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

Page last updated: August 20, 2015

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