Hypertension
Conditions
Keywords
Postoperative Hypertension
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.
Interventions
DRUGclevidipine
DRUGplacebo
Sponsors
The Medicines Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bailout during 30-minute treatment period | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed