A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,038
- 主要终点
- Any of the following within 30 days: Death from any cause; Myocardial infarction; Recurrent ischemic event requiring urgent intervention (repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk coronary angioplasty. The primary outcomes of the study include any of the following: the number of deaths from any cause, or myocardial infarctions and recurrent ischemic events requiring urgent intervention (e.g., repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).
Patients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for elective or urgent coronary balloon angioplasty or atherectomy with an FDA-approved device in one of the following settings: unstable angina or non-Q wave myocardial infarction, acute Q-wave myocardial infarction, or high-risk clinical/morphological characteristics
排除标准
- •Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment
- •Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit
- •Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis
- •Treated with oral anticoagulants within 7 days (unless prothrombin time is =< 1.2 times control) or intravenous dextran (before or planned for during the treatment angioplasty)
研究组 & 干预措施
Placebo
Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.
干预措施: Placebo (Drug)
Abciximab and Placebo
Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight of abciximab (c7E3 Fab) bolus injection followed by followed by placebo solution infusion up to 12 hours.
干预措施: Abciximab (Drug)
Abciximab and Placebo
Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight of abciximab (c7E3 Fab) bolus injection followed by followed by placebo solution infusion up to 12 hours.
干预措施: Placebo (Drug)
Abciximab
Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.
干预措施: Abciximab (Drug)
结局指标
主要结局
Any of the following within 30 days: Death from any cause; Myocardial infarction; Recurrent ischemic event requiring urgent intervention (repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).
时间窗: 30 days after angioplasty
次要结局
- Number of participants With use of thrombolytic agent in catheterization lab(Day 1)
- Time spent in catheterization lab(Day 1)
- Number of balloon Used inflations during angioplasty(Day 1)
- Number of Successful Angioplasty(Day 1)
- Reason for Specific Mortality(Up to end of study (30 days after angioplasty))
- Number of Abrupt Closure(Day 1)
- Number of participants with late major clinical events(30 days after angioplasty up to 6 months after angioplasty)