Effectiveness of Intracoronary Injection of Eptifibatide as Adjunctive Antiplatelet Therapy in Primary Coronary Intervention in Patients With ST Segment Elevation Acute Myocardial Infarction.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Coronary angiography
研究概览
简要总结
The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is of superior benefit than the routine intravenous administration of these agents.
In patients presenting with acute myocardial infarction, and undergoing primary coronary intervention, intracoronary administration of Eptifibatide may increase local drug concentration by several orders of magnitude and promote clot disaggregation with a minimal increase in systemic drug concentration, and in that way enhancing myocardial perfusion and survival.
详细描述
Patients will be randomized, prospectively, single blinded into one of two arms:1)intravenous administration of Eptifibatide and 2) intracoronary administration. The primary end-point will be the angiographic achievement of TIMI 3 flow at the infarct related artery and TIMI myocardial perfusion grade (blush) and the electrocardiographic surrogate of myocardial perfusion the ST segment resolution.
The secondary end-points will be the occurrence of bleeding or hemorrhagic complication according to TIMI classification and the LVEF at one month compared with baseline
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction candidate for primary coronary angioplasty, presenting within 12 hours of onset of pain and ability to clearly identified only one infarct related artery.
排除标准
- •Contraindications for antiplatelet therapy such as bleeding disorders,
- •Thrombocytopenia,
- •Severe uncontrolled hypertension,
- •Recent stroke (<6 months),
- •Intracranial hemorrhage at any time
- •Patients after recent major surgery (<30 days),
- •Previous myocardial infarction
- •Previous revascularization either by CABG or PCI and 9)patients presented with cardiogenic shock.
研究组 & 干预措施
Eptifibatide (intracoronary)
干预措施: Eptifibatide (Drug)
Eptifibatide (intravenous)
干预措施: Eptifibatide (Drug)
结局指标
主要结局
Coronary angiography
时间窗: At the time of the procedure
次要结局
- Electrocardiogram(90 min after the procedure)