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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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