Clinical trial NCT00093249: Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)
Official title: Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Pre-operative hypertension
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2004-10-07
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Incidence of bailout during 30-minute treatment period
timeFrame: During the first 30 minutes post study drug initiation
Secondary outcomes:
measure: Median time to target SBP lowering effect (defined as a reduction by 15% or more)
timeFrame: During the first 30 minutes post study drug initiation
measure: Mean arterial pressure (MAP) change from baseline
timeFrame: During the first 30 minutes post study drug initiation
measure: Heart rate change from baseline
timeFrame: During the first 30 minutes post study drug initiation
measure: Incidence of bailout by causality
timeFrame: During the first 30 minutes post study drug initiation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardio-Thoracic Surgeons, PC
state: Alabama
city: Los Angeles
country: United States
facility: St Vincent Medical Center
state: California
city: Hudson
country: United States
facility: Discovery Alliance - Hudson
state: Florida
city: Pensacola
country: United States
facility: Discovery Alliance - Sacred Heart Hospital
state: Florida
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Berwyn
country: United States
facility: MacNeal Hospital
state: Illinois
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital, The Linder Clinical Trial Center
state: Ohio
city: Houston
country: United States
facility: Memorial Herman Memorial City Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: Houston Northwest Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Hospital Medical Center
state: Washington
Study officials:
References:
citation: Levy JH, Mancao MY, Gitter R, Kereiakes DJ, Grigore AM, Aronson S, Newman MF. Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1. Anesth Analg. 2007 Oct;105(4):918-25, table of contents. doi: 10.1213/01.ane.0000281443.13712.b9.