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临床试验/NCT03785509
NCT03785509已完成不适用

The Effect of Persistence and Compliance of Antiplatelet and Dyslipidemia Agents on Cardiovascular Outcomes in Real World Patients Undergoing Percutaneous Coronary Intervention

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 47,291 人开始时间: 2017年4月6日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
47,291
试验地点
1
主要终点
Incidence density of MACE

研究概览

简要总结

A nationwide retrospective cohort study. To investigate the real world medication compliance and the relation with clinical outcomes.

The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. But, the discontinuation and compliance rate are unknown in the real world setting.

详细描述

A nationwide retrospective cohort study. The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. The discontinuation and uncompliance may increase a risk. But, the discontinuation and compliance rate are not well known in the real world patients undergoing bare metal stents(BMS) and drug eluting stents(DES) insertion.

To investigate the real world medication compliance and the relation with clinical outcomes, administrative claim data was extracted from the Korean National Healthcare Insurance(KNHI) database.

All Korean patient date undergoing PCI from January 1, 2011 to December 2011 is extracted. 5 year clinical outcomes are investigated.

Primary outcomes are the MACE including all-cause death, revascularization, critically ill status, and stroke) classified by the medication compliance. Medication complinace is measured by proportion of days covered(PDC)

Secondary outcomes are the patterns of medication persistence and its outcomes to understand critical points.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

接受健康志愿者

入选标准

  • All claim of percutaneous coronary intervention using stent in the National Healthcare Insurance Service of Korea between January 1st 2011 and December 31st, 2011

排除标准

  • No use of stents
  • Stent not classified into DES or BMS
  • Use of DES and BMS together at the same initial day

结局指标

主要结局

Incidence density of MACE

时间窗: 5 years

5 year incidence densities of a major adverse clinical events(MACEs) consisting of all-cause death, revascularization, critically ill status and stroke.

次要结局

  • Compliance defined as a proportion of days covered (%)(6 month)

研究者

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

Jin-Ho Choi

MD, PhD, Professor

Samsung Medical Center

研究点 (1)

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