Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Medicines Company
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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)
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
You may not be 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
Clareo Health | Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
