Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

NCT00093262 | Completed Phase 3 DMC

• 2 other identifiers: TMC-CLV-03-02ESCAPE-2
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 15

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.

Conditions

Hypertension

Keywords

Postoperative Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence of bailout during 30-minute treatment period

  The incidence of bailout defined as the premature and permanent discontinuation of study drug categorized according to the following reasons: * Bailout for lack of efficacy * Bailout for safety reason(s) * Bailout due to treatment failure

  During the first 30 minutes post study drug initiation

Secondary Outcomes (4)

• Median time to target SBP lowering effect (defined as a reduction by 15% or more)

  During the first 30 minutes post study drug initiation

• Mean arterial pressure (MAP) change from baseline

  During the first 30 minutes post study drug initiation

• Heart rate change from baseline

  During the first 30 minutes post study drug initiation

• Incidence of bailout by causality

  During the first 30 minutes post study drug initiation

Study Arms (2)

clevidipine

EXPERIMENTAL

Clevidipine was administered in a blinded fashion intravenously, starting with an infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/hr), titrating upward, as tolerated by the patient, in doubling increments approximately every 90 seconds up to an infusion rate of 3.2 μg/kg/min (16 mg/hr) to achieve the desired blood pressure-lowering effect. Up-titration to infusion rates above 3.2 μg/kg/min could be used, guided by the patient's response, by increasing the infusion rate in serial increments of 1.5 μg/kg/min, up to the maximum recommended clevidipine infusion rate of 8.0 μg/kg/min. Clevidipine was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.

Drug: clevidipine

placebo

PLACEBO COMPARATOR

Placebo consisted of 20% lipid emulsion (the same lipid vehicle used for clevidipine) administered in a blinded fashion intravenously following the same study drug administration guidelines as with clevidipine study drug administration guidelines. As with clevidipine, placebo was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.

Drug: placebo

Interventions

clevidipine DRUG

Also known as: clevidipine, Cleviprex

clevidipine

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Expected to survive beyond 24 hours post-surgical procedure
• 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

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (15)

Discovery Alliance - Mobile Infirmary Medical Center

Mobile, Alabama, 36602, United States

Location

Keck School of Medicine, University of Southern California

Los Angeles, California, 90033, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91109, United States

Location

Stanford University School of Medicine

Stanford, California, 94305-5640, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Heart Care Research Foundation

Blue Island, Illinois, 60406, United States

Location

MacNeal Hospital

Glencoe, Illinois, 60022, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

St. Lukes Hospital

Kansas City, Missouri, 64111, United States

Location

International Heart Institute

Missoula, Montana, 59802, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029-6574, United States

Location

Columbia University - College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin VAMC - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (1)

• 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.

  PMID: 18635468 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2004
• First Posted: October 7, 2004
• Study Start: December 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

US (15)