NCT00043784已完成3 期
A Prospective, Randomized, Open-Label, Multicenter Study in Patients Presenting With Acute Coronary Syndromes (ACS)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 8,000
- 试验地点
- 2
- 主要终点
- To measure the composite endpoint of all-cause mortality or the first clinical events committee (CEC)-adjudicated nonfatal myocardial infarction
研究概览
简要总结
Patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior.
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
- 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
- 未提供
排除标准
- •Known or suspected pregnancy
- •Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); active bleeding
- •Impaired hemostasis: 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/mL), or history of thrombocytopenia with GP IIb/IIIa inhibitor therapy, heparin, or enoxaparin
- •Angina from a secondary cause such as severe, uncontrolled hypertension (systolic blood pressure >180 mm Hg despite treatment); anemia; valvular disease; congenital heart disease; hypertrophic cardiomyopathy; restrictive or constrictive cardiomyopathy; thyrotoxicosis
- •PCI within the past 24 hours, not including coronary angiography only
- •Allergy to pork or pork products
- •Contraindications to UFH or LMWH
- •Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
- •Thrombolytic therapy within the preceding 24 hours
- •Other serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min
- •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
- •Inability to give informed consent or high likelihood of being unavailable for follow-up
- •Not a candidate for intervention, (angiography or PCI)
- •Treatment with a direct thrombin inhibitor or a low molecular weight heparin other than enoxaparin in the 7 days preceding enrollment.
结局指标
主要结局
To measure the composite endpoint of all-cause mortality or the first clinical events committee (CEC)-adjudicated nonfatal myocardial infarction
时间窗: within 30 days after randomization
To measure the incidence of major bleeding.
时间窗: during the index hospitalization
次要结局
- Incidence of minor and all bleeding(during the index hospitalization)
- To evaluate the combined and individual incidence of all-cause mortality, clinical events committee (CEC)-adjudicated nonfatal MI, stroke, or recurrent ischemia that required revascularization(within 14 and 30 days after randomization)
- To evaluate the incidence of all-cause mortality(within 6 months and 1 year after randomization)
- To evaluate the combined incidence of all-cause mortality or CEC-adjudicated nonfatal MI(within 14 days and all-cause mortality or nonfatal MI within 6 months after randomization)
研究者
研究点 (2)
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