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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.
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 nitroglycerin 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clevidipine | Experimental | Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative 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. |
|
| nitroglycerin | Active Comparator | Nitroglycerin (NTG) was initiated after insertion of an arterial line upon the occurrence of perioperative 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clevidipine | Drug |
|
| |
| nitroglycerin |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of death, stroke, MI and renal dysfunction | Initiation of study drug infusion through post-operative Day 30 |
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Prerandomization Inclusion Criteria:
Prerandomization Exclusion Criteria:
Postrandomization Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm Lloyd, MD | The Medicines Company - Medical Director, Clinical Operations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brookwood Medical Center | Birmingham | Alabama | 35209 | United States | ||
| Baptist Medical Center, Montclair |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18806012 | Result | 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. |
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| Drug |
|
| Birmingham |
| Alabama |
| 35213 |
| United States |
| Medical Center East | Birmingham | Alabama | 35235 | United States |
| Baptist Medical Center, South | Montgomery | Alabama | 36116 | United States |
| University Medical Center | Tucson | Arizona | 85724 | United States |
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | United States |
| Keck School of Medicine, University of Southern California | Los Angeles | California | 90033 | United States |
| Huntington Memorial Hospital | Pasadena | California | 91109 | United States |
| University of California | San Francisco | California | 94143-0648 | United States |
| Regional Medical Center - Bayonet Point | Hudson | Florida | 34667 | United States |
| Health First Holmes Regional Medical Center | Melbourne | Florida | 32901 | United States |
| Sacred Heart Health System | Pensacola | Florida | 32504 | United States |
| Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii | 96817 | United States |
| Saint Francis Hospital | Evanston | Illinois | 60202 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| St Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45219 | United States |
| The Christ Hospital, The Linder Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
| Memorial Herman Memorial City Hospital | Houston | Texas | 77024 | United States |
| Michael E DeBakey VA Medical Center | Houston | Texas | 77030-4211 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Houston Northwest Medical Center | Houston | Texas | 77090 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Saint Joseph Medical Center | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C118563 | clevidipine |
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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