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临床试验/NCT04861363
NCT04861363Unknown不适用

Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients- A Database Retrospective Study

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2019年6月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20,000
试验地点
1
主要终点
Ticagrelor persistence

研究概览

简要总结

This is a retrospective, observational, descriptive study which will include patients hospitalized for acute coronary syndrome (ACS) and treated with ticagrelor at discharge. Participants will come from the follow-up program of ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge. The primary objectives were to describe the ticagrelor treatment patterns-Ticagrelor persistence, discontinuation, switching, interruption and reasons in Chinese ACS patients; and also to describe 1-year clinical outcomes (Composite of any cause death, myocardial infarction, and stroke) of Chinese ACS patients in real-life practice based on ACS patient follow-up program database.

详细描述

Background: There are at least 2.5 million acute coronary syndromes (ACS) patients in China per year. Limited data about long term ticagrelor treatment patterns and clinical outcomes in Chinese ACS patients due to the lack of large high quality follow up database. This study is based on real-life practice and ticagrelor is prescribed according to the Chinese guideline and it takes place in real life.

Objective of this study:

Primary Objectives:

  1. To describe the ticagrelor treatment patterns-Ticagrelor persistence, discontinuation, switching, interruption and reasons for discontinuation/switching/interruption in Chinese ACS patients.
  2. To describe 1-year clinical outcomes (Composite of any cause death, myocardial infarction, and stroke) of Chinese ACS patients in real-life practice based on ACS patient follow-up program database.

Secondary Objectives:

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • ACS patients hospitalized during the following period: from January 2019 to September 2019
  • Patients receiving ticagrelor as part of DAPT at hospital discharge.
  • Patient enrolled into the follow-up program of ACS patients

排除标准

  • Patients participated in other interventional clinical trials

结局指标

主要结局

Ticagrelor persistence

时间窗: 12 months

Duration of ticagrelor treatment: Proportion of patients receiving ticagrelor each month after discharge; Duration from the start of treatment to the end of treatment.

Ticagrelor switch and reasons for switching

时间窗: 12 months

Percentage of patients with ticagrelor change and related causes: Switching refers to switching from ticagrelor/clopidogrel to another P2Y12 inhibitor (switching from clopidogrel to ticagrelor is a redressing, if documented)

Ticagrelor discontinuation and reasons for discontinuation

时间窗: 12 months

Percentage of patients with ticagrelor discontinuation and related causes: Discontinuation was defined as stopping P2Y12 for at least 3 months.

Ticagrelor interruption and reasons for interruption

时间窗: 12 months

Percentage of patients with ticagrelor interruption and related causes: Interruptionn was defined as drug withdrawal for more than 1 day and less than 3 months.

Major Adverse Cardiovascular Events

时间窗: 12 months

Time to the first occurence of Any cause death, myocardial infarction, or Stroke

次要结局

  • Any cause death(12 months)
  • Stroke(12 months)
  • Myocardial infarction(12 months)

研究者

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

Yong Huo

Former director of the Department of cardiology, Principal Investigator, Clinical professor

Peking University First Hospital

研究点 (1)

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