Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 patients with perioperative 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 nitroglycerin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Clevidipine; Nitroglycerin

Criteria

Prerandomization Inclusion Criteria:

• Provide written informed consent before initiation of any study related procedures.

• Be at least 18 years of age

• Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery

Prerandomization 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

• Known or suspected hypersensitivity to nitroglycerin

• Allergy to soybean oil or egg lecithin (components of the lipid vehicle)

• Pre-existing 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

Postrandomization Inclusion Criteria:

• Determined to be hypertensive perioperatively as determined by the investigator