NCT00077844已完成2 期
An International Phase 2-3, Stratified, Randomized, Open-label, Parallel-group Clinical Trial to Evaluate the Safety and Efficacy of a Single Intravenous Bolus of Enoxaparin Versus Intravenous Unfractionated Heparin in Patients Undergoing Non-emergent Percutaneous Coronary Intervention
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 3,532
- 主要终点
- the composite of non-CABG major and minor bleeding
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Male or non-pregnant female greater than or equal to 18 years of age
- •Undergoing non-emergent single or multiple sites/vessels PCI during the same procedure
- •PCI to be performed with a femoral approach
排除标准
- •Known or suspected pregnancy in women of childbearing potential
- •Thrombolytic therapy within the previous 24 hours
- •Undergoing primary PCI for ongoing ST-segment elevation myocardial infarction (STEMI)
- •Undergoing rescue PCI after failed thrombolysis
- •Any other elective PCI scheduled within the following 30 days after the index PCI
- •Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intracranial tumor or aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); active bleeding
- •Uncontrolled arterial hypertension
- •Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
- •Impaired haemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL)
- •History of hypersensitivity or contraindication to heparin or LMWH
- •Treatment with oral anticoagulant therapy within 72 hours prior to inclusion or current need for vitamin-K antagonist therapy
- •Treatment with a direct thrombin inhibitor, low molecular weight heparin, or unfractionated heparin within the 24 hours preceding enrolment
- •Use of abciximab within the previous 7 days or, tirofiban, or eptifibatide within the past 12 hours of index PCI
- •Inability to give informed consent or high likelihood of being unavailable for follow-up
- •Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial
结局指标
主要结局
the composite of non-CABG major and minor bleeding
时间窗: up to H48 after index PCI
次要结局
- success rate of achieving ACT target range(at the beginning and end of procedure)
研究者
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