Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

NCT ID: NCT00093925

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 739 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2006-09-30

Brief Summary

The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after 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 nicardipine.

Detailed Description

The primary objective was to establish the safety of clevidipine in the treatment of postoperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nicardipine treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

clevidipine

Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of postoperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above 3.2 μg/kg/min were permitted up to the maximum infusion rate of 8.0 μg/kg/min. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Infusion rates between 4.4 and 8.0 μg/kg/min were to be administered for no more than 2 hours.

Group Type: EXPERIMENTAL

clevidipine

Intervention Type: DRUG

nicardipine

Nicardipine (NIC) was initiated after insertion of an arterial line upon the occurrence of postoperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU.

Group Type: ACTIVE_COMPARATOR

nicardipine

Intervention Type: DRUG

Interventions

clevidipine

Intervention Type: DRUG

nicardipine

Intervention Type: DRUG

Other Intervention Names

clevidipine, Cleviprex

Eligibility Criteria

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

• Expected to survive beyond 24 hours post-surgical procedure
• No surgical complications or conditions, present or anticipated, that preclude them from inclusion in the study
• Determined to be hypertensive postoperatively as determined by the investigator

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 nicardipine
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Lloyd, MD

Role: STUDY_DIRECTOR

The Medicines Company - Medical Director, Clinical Operations

Locations

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Wesley Medical Center

Wichita, Kansas, United States

Touro Infirmary

New Orleans, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Columbia University - College of Physicians and Surgeons

New York, New York, United States

Jack D. Weller Hospital

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

VA Medical Center McGuire

Richmond, Virginia, United States

Countries

United States

References

Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.

Reference Type: RESULT

PMID: 18806012 (View on PubMed)

Other Identifiers

ECLIPSE-NIC

Identifier Type: OTHER

Identifier Source: secondary_id

TMC-CLV-03-05

Identifier Type: -

Identifier Source: org_study_id