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

Bayer

Status: Completed

Conditions: Ischemic Heart Disease; Coronary Heart Disease; Stroke; Secondary Prevention

Treatments: Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs; Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Study type: Observational

Funder types: Industry

Identifiers

NCT02550717

18116

Details and patient eligibility

About

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

Full 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.

Enrollment: 398,158 patients

Sex: All

Ages: 40 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

398,158 participants in 2 patient groups

Acetylsalicylic Acid

Description:

New users of low-dose Acetylsalicylic Acid (ASA)

Treatment:

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Other medications

Description:

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

Treatment:

Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs