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Completed

NCT Number: NCT02550717

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

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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Key information

Conditions

Secondary Prevention Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Coronary Heart Disease Heart Diseases Hemorrhage Ischemic Heart Disease Myocardial Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

Low-dose ASA for secondary prevention of cardiovascular events

Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs

Drug

Secondary prevention of cardiovascular events

Primary outcomes

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

    Time frame: Up to 13 years

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

    Time frame: Up to 13 years

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

    Time frame: Up to 13 years

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

    Time frame: Up to 13 years

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

    Time frame: Up to 13 years

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

    Time frame: Up to 13 years

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Pharmacoepidemiological Study on the Risk of Bleeding in New Users of Low-dose Aspirin (ASA) in The Health Improvement Network (THIN), UK

Acronym: EPISAT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2015
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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