Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients With Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9,406
- 主要终点
- Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
研究概览
简要总结
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).
详细描述
This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Willing and able to give informed consent and comply with study procedures and follow-up through 1 year.
- •Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours.
- •Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome.
- •Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following:
- •60 years of age or more
- •Electrocardiogram changes (ECG)
- •Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels
- •Or have all 3 of the following:
- •Prior history of cardiovascular disease
- •Elevated troponin or CK-MB levels
- •50-59 years of age
排除标准
- •pregnancy (known or suspected)
- •renal dialysis within 30 days prior to randomizing in study
- •other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated
- •Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma.
- •History of certain hematologic problems following treatment with heparin or eptifibatide.
- •Therapy with certain related drugs within a short time before randomization into the trial.
研究组 & 干预措施
Eptifibatide
Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
干预措施: Eptifibatide (Integrilin) (Drug)
Placebo
Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
时间窗: 96 hours after randomization
次要结局
- Incidence of the Composite of Death/MI.(30 days after randomization)