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

Completed

• Conditions: Secondary Prevention; Coronary Heart Disease; Stroke; Ischemic Heart Disease
• Interventions: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs

• Registration Number: NCT02550717
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398158

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acetylsalicylic Acid	Acetylsalicylic Acid (Aspirin, BAYE4465)	New users of low-dose Acetylsalicylic Acid (ASA)
Other medications	Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs	Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs)

Primary Outcome Measures

Name	Time	Method
Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.	Up to 13 years
Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA	Up to 13 years
Time to Intracranial bleeding among new users of low-dose ASA	Up to 13 years
Time to Upper gastrointestinal bleeding among new users of low-dose ASA	Up to 13 years
Time to Lower gastrointestinal bleeding among new users of low-dose ASA	Up to 13 years
Relative risk of Intracranial bleeding among new users of low dose ASA	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).	Up to 13 years
Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA	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	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.

Secondary Outcome Measures

Name	Time	Method
Relative risk of Intracranial bleeding associated with use of other medications.	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.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly
Relative risk of Upper gastrointestinal bleeding associated with use of other medications	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.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly
Relative risk of Lower gastrointestinal bleeding associated with use of other medications.	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.To estimate relative risk in users of other medications such as clopidogrel,oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs), independently from use of low-dose ASA and concomitantly