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临床试验/NCT03904732
NCT03904732已完成不适用

Predictive Modelling of the Effects of Regular Low-dose Aspirin on COlorectal Cancer, Cardiovascular Disease and Safety Outcomes in Europe: PEACOCS Model EU

Bayer1 个研究点 分布在 1 个国家目标入组 2,000,000 人开始时间: 2019年4月15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
2,000,000
试验地点
1
主要终点
Number of myocardial infarction and ischaemic stroke

研究概览

简要总结

In this study researchers want to learn more about the effect of low-dose Aspirin on cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus), diseases that affects the heart or blood vessels and safety outcomes. Study will focus on two groups of adults aged 50-59 and 60-69 years having an increased risk of heart and/or blood vessel disease who are taking either low-dose aspirin or no low-dose aspirin for heart and/or blood vessel disease prevention. The model will be based on information publicly available either on government organization websites or in scientific journals. Based on these data researchers will focus in a first step to build a model of 2 million adults (1 million for each age group) for the UK population and in a second step, the model will be modified for use with other European countries, to reflect the epidemiology and guidelines for aspirin use in these countries.

详细描述

Observational Study Model is selected as "Other" - Reason: Individual-level state transition model simulating the number of events of CRC, CVD, safety events and deaths in hypothetical cohorts of 1 million adults aged 50-59 years and 1 million adults aged 60-69 years followed for 20 years or till death, whichever comes first. The hypothetical cohorts are reflective of a population eligible for taking aspirin for primary or secondary CVD prevention.

Time Perspective is also selected as "Other"

  • Reason: Individual-level state transition model built mimicking the UK population using data published in scientific international peer-reviewed journals or published data from government agencies. In a second phase, the model results will be extrapolated to other EU countries, modifying the model parameters to reflect the other EU countries epidemiology.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
50 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • European populations (UK and other European countries) of adults aged 50-59 and 60-69 years eligible for using aspirin for primary or secondary CVD prevention. Subjects are eligible when they have no contra-indications, and are at increased risk of CVD (primary prevention) or have suffered from a previous CVD event

排除标准

  • 未提供

研究组 & 干预措施

Cohort 1

hypothetical UK populations of adults aged 50-59 take low-dose aspirin for primary prevention

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

Cohort 2

hypothetical UK populations of adults aged 50-59 take low-dose aspirin for secondary prevention

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

Cohort 5

hypothetical UK populations of adults aged 60-69 take low-dose aspirin for primary prevention

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

Cohort 6

hypothetical UK populations of adults aged 60-69 take low-dose aspirin for secondary prevention

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

结局指标

主要结局

Number of myocardial infarction and ischaemic stroke

时间窗: Up to 20 years

Calculated results using a mimicked population

Number of severe gastrointestinal (GI) bleeding requiring hospitalization

时间窗: Up to 20 years

Calculated results using a mimicked population

Number of death due to myocardial infarction or due to ischaemic stroke

时间窗: Up to 20 years

Calculated results using a mimicked population

Number of colorectal cancer (CRC)

时间窗: Up to 20 years

Calculated results using a mimicked population

Number of symptomatic peptic ulcers requiring hospitalization

时间窗: Up to 20 years

Calculated results using a mimicked population

Number of deaths due to any other cause

时间窗: Up to 20 years

Calculated results using a mimicked population

Number of death due to CRC

时间窗: Up to 20 years

Calculated results using a mimicked population

Number of intracranial hemorrhage (ICH)

时间窗: Up to 20 years

Calculated results using a mimicked population

次要结局

未报告次要终点

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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