Overview

Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Medicines Company
Treatments:
Antihypertensive Agents
Clevidipine
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