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临床试验/NCT01888575
NCT01888575已完成不适用

Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention

AstraZeneca1 个研究点 分布在 1 个国家目标入组 35,604 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
35,604
试验地点
1
主要终点
Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use

研究概览

简要总结

This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are:

To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding.

To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex.

To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.

详细描述

Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention

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
50 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 50-84 years in 2000-
  • Patients with first prescription of low dose ASA ( see study population description).
  • Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study.

排除标准

  • Patients aged below age 50 and 85 years and above ( see study population description).
  • Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
  • Incomplete data recording in THIN.

研究组 & 干预措施

Aspirin discontinuers; Aspirin non-discontinuers

Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin

干预措施: Risk of low dose aspirin discontinuation (Drug)

结局指标

主要结局

Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use

时间窗: Up to 1 year.

Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.

Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)

时间窗: Up to 1 year

Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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