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 AE profile between treatments was limited2
- Many adverse events were associated with the operative procedure
- Relatively few were plausibly related to CLEVIPREX and the comparators
- AEs 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.