A Pharmacoepidemiological Study on the Risk of Bleeding in New Users of Low-dose Aspirin (ASA) in The Health Improvement Network (THIN), UK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 398,158
- 主要终点
- Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.
研究概览
简要总结
To investigate the risk of major bleeding (including gastrointestinal and intracranial bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical practice
详细描述
These will be based on population-based cohorts using data from a primary care database in the UK: The Health Improvement Network (THIN) and will serve to make a clinically meaningful benefit-risk assessment regarding major bleeding consequences of ASA exposure in general population.
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
- 40 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-84 years
- •Enrolled with the Primary Care Physician (PCP) for at least 2 years,
- •To have a history of computerized prescriptions for at least 1 year prior
- •To have at least one encounter/visit recorded in the last three years
排除标准
- •To be exposed to low dose ASA before entering in the study
- •Having a diagnosis of cancer before entering in the study
- •Having a diagnosis of alcohol abuse before entering in the study
- •Having a diagnosis of coagulopathies before entering in the study
- •Having a diagnosis of esophageal varices before entering in the study
- •Having a diagnosis of chronic liver disease before entering in the study
研究组 & 干预措施
Acetylsalicylic Acid
New users of low-dose Acetylsalicylic Acid (ASA)
干预措施: Acetylsalicylic Acid (Aspirin, BAYE4465) (Drug)
Other medications
Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs)
干预措施: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs (Drug)
结局指标
主要结局
Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.
时间窗: Up to 13 years
Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA
时间窗: Up to 13 years
Time to Intracranial bleeding among new users of low-dose ASA
时间窗: Up to 13 years
Time to Upper gastrointestinal bleeding among new users of low-dose ASA
时间窗: Up to 13 years
Time to Lower gastrointestinal bleeding among new users of low-dose ASA
时间窗: Up to 13 years
Relative risk of Intracranial bleeding among new users of low dose ASA
时间窗: Up to 13 years
Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.
Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).
时间窗: Up to 13 years
Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA
时间窗: Up to 13 years
Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.
Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA
时间窗: Up to 13 years
Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.
次要结局
- Relative risk of Intracranial bleeding associated with use of other medications.(Up to 13 years)
- Relative risk of Upper gastrointestinal bleeding associated with use of other medications(Up to 13 years)
- Relative risk of Lower gastrointestinal bleeding associated with use of other medications.(Up to 13 years)