Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)

Condition(s) targeted: Hypertension

Intervention: clevidipine (Drug); sodium nitroprusside (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: The Medicines Company

Official(s) and/or principal investigator(s):
Malcolm Lloyd, MD, Study Director, Affiliation: The Medicines Company - Medical Director, Clinical Operations

The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 250-500 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 sodium nitroprusside.

Official title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of death, stroke, MI and renal dysfunction

Detailed description: The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and sodium nitroprusside 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 sodium nitroprusside

- 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

Baptist Medical Center, Montclair, Birmingham, Alabama 35213, United States

Brookwood Medical Center, Birmingham, Alabama 35209, United States

Saint Vincents Hospital, Birmingham, Alabama 35205, United States

Baptist Medical Center, South, Montgomery, Alabama 36101, United States

Drug Research and Analysis Corporation, Montgomery, Alabama 36106, United States

Providence Saint Joseph Medical Center, Burbank, California 91505, United States

Stanford University Medical Center, Stanford, California 94305, United States

Shands Hospital at the University of Florida, Gainesville, Florida 32610, United States

Health First Holmes Regional Medical Center, Melbourne, Florida 32901, United States

Kaiser Permanente, Honolulu, Hawaii 96817, United States

St. Francis Hospital and Health Center, Blue Island, Illinois 60406, United States

St. Francis Hospital of Evanston, Evanston, Illinois 60202, United States

Wesley Medical Center, Wichita, Kansas 67214, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Touro Infirmary, New Orleans, Louisiana 70115, United States

St. Joseph Medical Center, Towson, Maryland 21204, United States

Massachussettes General Hospital, Boston, Massachusetts 02114, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Saint Lukes Hospital, Duluth, Minnesota 55805, United States

International Heart Institute/St. Patrick Hospital, Missoula, Montana 59802, United States

Mt. Sinai Medical Center, New York, New York 10029-6574, United States

The Christ Hospital, Cincinnati, Ohio 45219, United States

Portland VA Medical Center, Portland, Oregon 97239, United States

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Jackson-Madison County General Hospital, Jackson, Tennessee 38301, United States

Houston Northwest Medical Center, Houston, Texas 77090, United States

LDS Hospital, Salt Lake City, Utah 84112, United States

Virginia Commonwealth University Medical Center, Richmond, Virginia 23298, United States

Medical College of Wisconsin VAMC - Milwaukee, Milwaukee, Wisconsin 53295, United States

Starting date: June 2004
Last updated: May 5, 2014