NCT00093184已完成3 期
A Study Evaluating the Safety and Efficacy of Bivalirudin in the Management of Patients With ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI (BIAMI)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Reduction in bleeding complications
研究概览
简要总结
The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients >18 years of age.
- •Symptoms of STEMI for at least 30 min within previous 12 hours AND
- •ST-segment elevation in at least 2 contiguous leads or new Left Branch Bundle Block (LBBB), OR existing LBBB with positive troponin
- •Residual high grade stenosis and associated abnormalities in regional wall motion.
- •Planned primary PCI in native coronary vessel.
排除标准
- •Confirmed pregnancy
- •Fibrinolytic therapy - Any alteplase, reteplase, tenectoplase, or streptokinase within the last 24 hours
- •Culprit lesion within SVG or bypass conduit
- •Dependency on renal dialysis
- •Administration of LMWH within 8 hours prior to PCI
- •Administration of abciximab within 7 days prior to PCI
- •Administration of eptifibatide or tirofiban within 12 hours prior to PCI
- •Warfarin MUST BE discontinued prior to procedure, and the INR must be ⎕1.5, or the PT<15,
- •Heparin. If heparin is administered in the ER as long as it is discontinued at least 30 minutes prior to procedure, OR ACT <250, a patient may be enrolled. No clotting measurements are required if patient received heparin ⎕30 minutes prior to the initiation of bivalirudin.
- •Allergy to heparin or bivalirudin, or known sensitivity to any component of the products
- •Allergy to aspirin, clopidogrel, or abciximab
- •Contraindication to abciximab
- •Angiomax within 24 hours prior to study drug administration
- •Neurosurgery with three months
- •Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry (BP >180/110 mm Hg)
- •Cardiogenic shock (SBP <80 for >30 min or a need for intravenous pressors)
- •Stroke within three months
- •Any hemorrhagic diathesis
- •Life expectancy <1 year
- •Participation in another clinical trial
结局指标
主要结局
Reduction in bleeding complications
次要结局
未报告次要终点
研究者
研究点 (2)
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