Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 739
- 试验地点
- 9
- 主要终点
- Incidence of death, stroke, MI, and renal dysfunction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: clevidipine (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.
干预措施: nicardipine (Drug)
结局指标
主要结局
Incidence of death, stroke, MI, and renal dysfunction
时间窗: Initiation of study drug infusion through post-operative Day 30
次要结局
未报告次要终点