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

Bayer398,158 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

398,158

Conditions

Secondary Prevention Stroke Ischemic Heart Disease Coronary Heart Disease

Interventions

Acetylsalicylic Acid (Aspirin, BAYE4465)DRUG

Low-dose ASA for secondary prevention of cardiovascular events

Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIsDRUG

Secondary prevention of cardiovascular events

Eligibility

Sex: ALLMin age: 40 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Multiple Locations, United Kingdom

Outcomes

Primary Outcomes

Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).

Time frame: Up to 13 years

Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.

Time frame: Up to 13 years

Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA

Time frame: Up to 13 years

Time to Intracranial bleeding among new users of low-dose ASA

Time frame: Up to 13 years

Time to Upper gastrointestinal bleeding among new users of low-dose ASA

Time frame: Up to 13 years

Time to Lower gastrointestinal bleeding among new users of low-dose ASA

Time frame: Up to 13 years

Relative risk of Intracranial bleeding among new users of low dose ASA

Time frame: Up to 13 years

Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA

Time frame: Up to 13 years

Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA

Data from ClinicalTrials.gov

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Secondary Outcomes

Relative risk of Intracranial bleeding associated with use of other medications.

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

Time frame: Up to 13 years

Relative risk of Upper gastrointestinal bleeding associated with use of other medications

Time frame: Up to 13 years

Relative risk of Lower gastrointestinal bleeding associated with use of other medications.

Time frame: Up to 13 years