Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093249
First received: October 5, 2004
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.


Condition Intervention Phase
Hypertension
Drug: clevidipine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Incidence of bailout during 30-minute treatment period.

Secondary Outcome Measures:
  • During the 30-minute treatment period: time to SBP reduction by 15% or more; mean
  • arterial pressure change from baseline; heart rate change from baseline; incidence of bailout by causality.

Enrollment: 105
Study Start Date: January 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clevidipine Drug: clevidipine
Clevidipine (0.5 mg/mL in 20% lipid emulsion)will be administered intravenously at an initial infusion rate of 0.4 µg/kg/min and will be titrated, as tolerated, at the discretion of the investigator, in doubling increments approximately every 90 seconds up to a maximum of 3.2 µg/kg/min, in order to achieve the desired blood pressure lowering effect. Clevidipine may be titrated upwards or downwards and may be temporarily interrupted and restarted to attain the desired blood pressure effect. The maximum study drug infusion rate of 8.0 µg/kg/min may not be exceeded.
Other Name: Clevelox™, Cleviprex™
Placebo Comparator: placebo Drug: placebo
Placebo (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.

Detailed Description:

Initiation of study drug infusion will commence with the occurrence of protocol-defined preoperative hypertension (SBP > 160 mmHg) as measured via an indwelling arterial line.

The study drug (clevidipine or placebo) may be administered to treat hypertension until one hour has elapsed, or until induction of anesthesia, whichever occurs first.

The primary endpoint of bailout described (as defined per protocol) as bailout for lack of efficacy, bailout for safety reason or bailout due to treatment failure will be determined during the 30-minute period from study drug initiation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  • Have a recent history (within 6 months of randomization) of hypertension requiring treatment with antihypertensive medication(s) or be actively hypertensive upon admission

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:

  • After the insertion of an arterial line, the patient is determined to meet the per protocol preoperative definition of hypertension, i.e. systolic blood pressure (SBP) > 160 mmHg
  • It is the investigator's intent to lower the patient's SBP by a minimum of 15% from its baseline value
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093249

Locations
United States, Alabama
Cardio-Thoracic Surgeons, PC
Birmingham, Alabama, United States, 35213
United States, California
National Institute of Clinical Research
Los Angeles, California, United States, 90017
United States, Florida
Discovery Alliance - Hudson
Hudson, Florida, United States, 34667
Discovery Alliance - Sacred Heart Hospital
Pensacola, Florida, United States, 32503
United States, Georgia
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30322
United States, Illinois
MacNeal Hospital
Berwyn, Illinois, United States, 60402
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Christ Hospital, The Linder Clinical Trial Center
Cincinnati, Ohio, United States, 45219
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
Memorial Herman Memorial City Hospital
Houston, Texas, United States, 77024
United States, Washington
Swedish Hospital Medical Center
Seattle, Washington, United States, 98104-1318
Sponsors and Collaborators
The Medicines Company
  More Information

Publications:
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00093249     History of Changes
Other Study ID Numbers: TMC-CLV-03-01, ESCAPE-1
Study First Received: October 5, 2004
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Pre-operative hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014