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临床试验/NCT01261832
NCT01261832Unknown4 期

Randomized, Prospective , Open Label, Phase 4 Trial of Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention With Drug-eluting Stent

Korea University Guro Hospital1 个研究点 分布在 1 个国家目标入组 951 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
951
试验地点
1
主要终点
Major Adverse Cardiovascular and Cerebral Events

研究概览

简要总结

Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently, clinical research about the triple antiplatelet therapy including cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy for acute myocardial infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy and investigate ideal duration of triple antiplatelet therapy through this research.

详细描述

Drug-eluting stents (DES) have drastically changed the landscape of percutaneous coronary intervention (PCI), with significant reductions in the angiographic restenosis rate and need for repeated revascularization. However, several studies showed that DES is associated with a higher incidence of in-stent thrombosis compared with bare metal stents. Therefore, the latest guideline for antiplatelet therapy after PCI with DES suggests that the dual antiplatelet therapy (aspirin plus clopidogrel) be administered for at least 12 months.But is it enough for high-risk patients? Some studies showed that as many as 50% of the patients who received PCI did not react positively to aspirin or clopidogrel.Furthermore, there is increased platelet activity in acute coronary syndrome, especially in acute myocardial infarction (AMI). compared with aspirin or clopidogrel.A recent study suggested that cilostazol could ameliorate platelet responsiveness to clopidogrel in patients who underwent primary PCI. Furthermore, some other studies showed that the administration of cilostazol after PCI could significantly lower the incidence of in-stent restenosis. Therefore, the present study is designed to evaluate the safety and efficacy of additional administration of cilostazol with aspirin and clopidogrel in a real-world cardiology practice among patients presenting with AMI who received primary PCI with DES.

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

入选标准

  • Acute Myocardial Infarction Undergoing Primary percutaneous coronary intervention.

排除标准

  • The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol
  • Uncontrolled hypertension
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
  • Baseline hemogram with Hb<10g/dL or PLT count<100,000/μL
  • Patients already taking warfarin, cilostazol or any other type of anti-platelet agents except aspirin and clopidogrel
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

研究组 & 干预措施

Dual antiplatelet therapy for 1 year

Experimental

Dual antiplatelet therapy for 1 year : dual antiplatelet combination therapy with aspirin and clopidogrel for 1 year

干预措施: antiplatelet therapy (Drug)

Triple antiplatelet therapy for 1 month

Experimental

Triple antiplatelet therapy for 1 month : triple antiplatelet therapy including cilostazol for 1 month and after then, dual antiplatelet therapy for 11 months

干预措施: antiplatelet therapy (Drug)

Triple antiplatelet therapy for 6 months

Experimental

Triple antiplatelet therapy for 6 months : triple antiplatelet combination therapy including cilostazol for 6 months and after then, dual antiplatelet therapy for 6 months and cilostazol

干预措施: antiplatelet therapy (Drug)

结局指标

主要结局

Major Adverse Cardiovascular and Cerebral Events

时间窗: One Year

Composite of total death, Nonfatal Myocardial Infarction (Non-QMI , Q-MI), Repeat RevascularizationI (Target Vessel Revascularization +Non Target Vessel Revascularization , Coronary Artery Bypass Graft), Stroke (Ischemic \& Hemorrhagic)

次要结局

  • Individual outcome of primary end points, Stent thrombosis,Bleeding Complication,PFT (Platelet function test),Genotyping results(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seung Woon Rha

Associate professor

Korea University Guro Hospital

研究点 (1)

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