CLEVIPREX® (clevidipine) demonstrated safety in multiple clinical trials
The ECLIPSE study design1
3 parallel, prospective, randomized, open-label studies in patients undergoing cardiac surgery at 61 medical centers (N=1506)
Primary Endpoint: Safety, defined as incidence of death, MI, stroke, or renal dysfunction at 30 days vs comparators. Study was not powered for non-inferiority or superiority.
Secondary Endpoint: Efficacy by measuring the magnitude and duration of blood pressure excursions above or below a pre-defined SBP range vs comparators.
*Numbers for safety population. MI=myocardial infarction; SBP=systolic blood pressure.
Incidence of serious adverse events in ECLIPSE trials1,2
The adverse events observed within 1 hour of the end of infusion were similar in patients who received CLEVIPREX and those who received comparator agents.2
The ability to differentiate the adverse event profile between treatments was limited2
- Many adverse events were associated with the operative procedure
- Relatively few were plausibly related to CLEVIPREX and the comparators
- Adverse events observed within 1 hour of the end of infusion were similar between patients who received CLEVIPREX and those who received comparators
- No adverse reactions were >2% more common with CLEVIPREX compared with the average of all the comparators
Common adverse events (AEs) by day 7 or discharge vs placebo in the perioperative setting
†In ESCAPE-1 (preoperative), AEs reported by >5.7% of CLEVIPREX-treated patients from study drug initiation until hospital discharge or 7 days.
‡In ESCAPE-2 (postoperative), AEs reported by ≥10% of CLEVIPREX-treated patients from study drug initiation until hospital discharge or 7 days.
ESCAPE-13 and ESCAPE-24 Study Design
These results are from two double-blind, randomized, parallel, placebo-controlled, multicenter trials of cardiac surgery patients—preoperative use (n=105) and postoperative use (n=110). Patients were undergoing coronary artery bypass grafting with or without valve replacement. The primary endpoint was the incidence of treatment failure, defined as the inability to decrease SBP by ≥15% from baseline, or the discontinuation of study treatment for any reason within the 30-minute period after study drug initiation.