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Completed

NCT Number: NCT00093262

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Discovery Alliance - Mobile Infirmary Medical Center, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clevidipine

Drug

Other names: clevidipine, Cleviprex

Placebo

Drug

Primary outcomes

  1. Incidence of bailout during 30-minute treatment period

    Time frame: During the first 30 minutes post study drug initiation

    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

Secondary outcomes

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

    Time frame: During the first 30 minutes post study drug initiation

  2. Mean arterial pressure (MAP) change from baseline

    Time frame: During the first 30 minutes post study drug initiation

  3. Heart rate change from baseline

    Time frame: During the first 30 minutes post study drug initiation

  4. Incidence of bailout by causality

    Time frame: During the first 30 minutes post study drug initiation

Sponsors and collaborators

Lead sponsor

The Medicines Company

Industry

Registry information

Official study title

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

Acronym: ESCAPE-2

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 7, 2004
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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