Clinical trial NCT00093262: Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
Official title: Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Postoperative Hypertension
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2004-10-07
Enrollment: 206
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 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.

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 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

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: Mobile
country: United States
facility: Discovery Alliance - Mobile Infirmary Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: Keck School of Medicine, University of Southern California
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Blue Island
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Glencoe
country: United States
facility: MacNeal Hospital
state: Illinois
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Kansas City
country: United States
facility: St. Lukes Hospital
state: Missouri
city: Missoula
country: United States
facility: International Heart Institute
state: Montana
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University - College of Physicians and Surgeons
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Houston
country: United States
facility: Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin VAMC - Milwaukee
state: Wisconsin
Study officials:
References:
citation: Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.