Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2017-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Secondary Prevention Stroke Ischemic Heart Disease Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Acetylsalicylic Acid

New users of low-dose Acetylsalicylic Acid (ASA)

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

Low-dose ASA for secondary prevention of cardiovascular events

Other medications

Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs)

Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs

Intervention Type DRUG

Secondary prevention of cardiovascular events

Interventions

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Acetylsalicylic Acid (Aspirin, BAYE4465)

Low-dose ASA for secondary prevention of cardiovascular events

Intervention Type DRUG

Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs

Secondary prevention of cardiovascular events

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No