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临床试验/NCT04097912
NCT04097912已完成不适用

Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE Using OHDSI

Bayer1 个研究点 分布在 1 个国家目标入组 99,999 人开始时间: 2019年9月30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
发起方
Bayer
入组人数
99,999
试验地点
1
主要终点
Adherence to low-dose aspirin

研究概览

简要总结

This study aims to gather information to what extent patients follow the treatment regimen of low-dose aspirin for primary and secondary prevention of diseases of the heart and blood vessels. Researcher will collect information about the percentage of time a patient has access to the medication, how long patients continue with the medication and of the proportion of patients who switch from dual-antiplatelet therapy (including low-dose aspirin) to a single antiplatelet therapy. The study will make use of secondary healthcare data sources converted in to Observational Medical Outcomes Partnership (OMOP) common data model within the Observational Health Data Sciences and Informatics (OHDSI) network.

研究设计

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

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

  • Aged ≥18 years
  • Patients will be selected if they have at least two prescriptions for low-dose aspirin (75-100 mg) between 2008 and 2018 for either:
  • Primary prevention of CVD This is defined as patients who have no history of CVD any time prior to initiation of low-dose aspirin treatment are presumed to use for primary CVD prevention
  • Secondary prevention of CVD This is defined as patients who have a history of CVD any time prior to initiation of low-dose aspirin treatment
  • Patients with at least two prescriptions of low-dose aspirin with a dosage of 75-100mg within the first year of the index date.
  • Restricted to patients with observation for at least 12 months before and 12 after the index date.

排除标准

  • Prescription of low-dose aspirin in 12 months before the index date.

研究组 & 干预措施

Low-dose aspirin users

Patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of cardiovascular disease (CVD).

干预措施: Acetylsalicylic Acid (Aspirin, BAYE4465) (Drug)

结局指标

主要结局

Adherence to low-dose aspirin

时间窗: Retrospective analysis from 2007 to 2018

Adherence low-dose aspirin use will be represented by the medication possession ratio (MPR)

Persistence to low-dose aspirin

时间窗: Retrospective analysis from 2007 to 2018

In terms of continuation and discontinuation: * Continuation at 30 and 60 day gaps * Discontinuation: * If patients switched to another antiplatelet therapy * If patients reinitiated low-dose aspirin \>30 days and \>60 days after end of supply i.e. of the pre-specified gap was exceeded * If patients stopped low-dose aspirin therapy completely

次要结局

  • Time to switch from dual-antiplatelet to a monotherapy(Retrospective analysis from 2007 to 2018)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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