Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)
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 determine the efficacy of clevidipine injection versus
placebo in treating preoperative hypertension.
Clinical Details
Official title: Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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:
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
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)
- 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
Locations and Contacts
Cardio-Thoracic Surgeons, PC, Birmingham, Alabama 35213, United States
St Vincent Medical Center, Los Angeles, California 90057, United States
Discovery Alliance - Hudson, Hudson, Florida 34667, United States
Discovery Alliance - Sacred Heart Hospital, Pensacola, Florida 32503, United States
Atlanta VA Medical Center, Atlanta, Georgia 30322, United States
MacNeal Hospital, Berwyn, Illinois 60402, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, United States
The Christ Hospital, The Linder Clinical Trial Center, Cincinnati, Ohio 45219, United States
Houston Northwest Medical Center, Houston, Texas 77090, United States
Memorial Herman Memorial City Hospital, Houston, Texas 77024, United States
Texas Heart Institute, Houston, Texas 77030, United States
Swedish Hospital Medical Center, Seattle, Washington 98104-1318, United States
Additional Information
Starting date: January 2004
Last updated: August 21, 2014
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