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临床试验/NCT04734028
NCT04734028已完成不适用

Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients : A Consortium From Multi-centered Registries

Gyeongsang National University Hospital1 个研究点 分布在 1 个国家目标入组 13,160 人开始时间: 2003年7月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
13,160
试验地点
1
主要终点
MACCE

研究概览

简要总结

The PTRG-DES consortium is a coalition composed of multi-center, real-world registries including CAD patients treated with DES in South Korea. From 9 academic registries in Korea, a total of 13,160 patients were enrolled for this database between July 2003 and August 2018. The aim of the study was to investigate long-term prognostic implications of platelet function and genotypes after DES implantation for significant CAD in South Korea.

详细描述

The investigators enrolled patients treated with DES during DAPT including clopidogrel who had at least one of VerifyNow test (PRU and ARU) and genotyping. In this consortium, the investigators tried to find the unique characteristics of East Asians based on platelet function, genotype and inflammatory markers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Consecutive patients at every centre successfully treated with one or more DES approved by the US FDA or CE mark and who were adequately loaded with clopidogrel were eligible for enrolment, regardless of patient or lesion complexity.

排除标准

  • the occurrence of a major complication during the procedure or before platelet function testing, or if bypass surgery was planned after PCI.
  • Any P2Y12 inhibitor other than clopidogrel
  • PCI strategy other than DES
  • Needed oral anticoagulant (e.g. atrial fibrillation)

研究组 & 干预措施

PTRG-DES registry

After DES implantation, CAD patients were treated with DAPT with clopidogrel and aspirin. During hospitalization, their platelet function, genotype and inflammation biomarker were evaluated.

干预措施: Clopidogrel Tablets (Drug)

结局指标

主要结局

MACCE

时间窗: upto 10 years

All-cause death, MI, stroke or stent thrombosis

次要结局

  • MACE1(upto 10 years)
  • Each clinical event(upto 10 years)
  • MACE2(upto 10 years)
  • Major bleeding(upto 10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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