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

Sponsor

The Medicines Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00093925

Collaborator

(none)

739

Enrollment

Locations

Arms

Duration (Months)

82.1

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: clevidipine Drug: nicardipine	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

739 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: clevidipine Other Names: clevidipine, Cleviprex
Active Comparator: 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.	Drug: nicardipine

Arm

Intervention/Treatment

Experimental: 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.

Drug: clevidipine

Other Names:

clevidipine, Cleviprex

Active Comparator: 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.

Drug: nicardipine

Outcome Measures

Primary Outcome Measures

Incidence of death, stroke, MI, and renal dysfunction [Initiation of study drug infusion through post-operative Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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

Postrandomization 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 the study
Determined to be hypertensive postoperatively as determined by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36607
2	Wesley Medical Center	Wichita	Kansas	United States	67214
3	Touro Infirmary	New Orleans	Louisiana	United States	70115
4	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
5	Jack D. Weller Hospital	Bronx	New York	United States	10461
6	Montefiore Medical Center	Bronx	New York	United States	10467
7	Columbia University - College of Physicians and Surgeons	New York	New York	United States	10032
8	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
9	VA Medical Center McGuire	Richmond	Virginia	United States	23249

Sponsors and Collaborators

The Medicines Company

Investigators

Study Director: Malcolm Lloyd, MD, The Medicines Company - Medical Director, Clinical Operations

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Medicines Company

ClinicalTrials.gov Identifier:

NCT00093925

Other Study ID Numbers:

TMC-CLV-03-05
ECLIPSE-NIC

First Posted:

Oct 8, 2004

Last Update Posted:

May 6, 2014

Last Verified:

May 1, 2014

Keywords provided by The Medicines Company

Postoperative hypertension

Additional relevant MeSH terms:

Hypertension

Nicardipine

Clevidipine

Study Results

No Results Posted as of May 6, 2014