NCT00507338终止2 期
A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- adequacy of reperfusion
研究概览
简要总结
ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.
详细描述
Adjunctive anti-thrombotic therapy for PCI of AMI may be improved by incorporation of a novel anti-platelet therapeutic principle, von Willebrand Factor antagonism. ARC1779 is a therapeutic oligonucleotide ("aptamer") which blocks the binding of the A1 domain of vWF to the platelet GPIb receptor, and thereby modulates platelet adhesion, activation, and aggregation under the high shear conditions of coronary arterial stenosis and plaque rupture. This study is intended to provide dose-ranging and clinical proof of concept for ARC1779 in a primary PCI population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •troponin-positive NSTEMI, with diagnostic symptoms and/or ECG abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
- •STEMI, with planned primary PCI
排除标准
- •History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
- •Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
- •Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
- •Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy
- •Major surgery or trauma within the preceding 6 weeks
- •History of stroke within 30 days or any history of hemorrhagic stroke
- •End-stage renal disease (ESRD) with dependency on renal dialysis
结局指标
主要结局
adequacy of reperfusion
时间窗: 48 hours post-PCI
次要结局
- bleeding(PCI to hospital discharge)
研究者
研究点 (2)
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