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

October 23, 2018 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

398158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

THIN is a computerized medical research database that contains systematically recorded data on more than 3 million UK primary care patients. It is representative of this population with regard to age, sex, and geographic distribution, and has been validated for use in pharmacoepidemiological and epidemiological research in multiple studies 13. Participating Primary Care Physicians (PCPs) record prospectively data as part of their routine patient care, including demographics and life style factors (e.g. alcohol use, body mass index (BMI) and smoking status), consultation rates, referrals, hospital admissions, laboratory test results, diagnoses, prescriptions ordered by the PCPs, and a free text section, and send their data anonymously to THIN for use in research projects.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acetylsalicylic Acid
New users of low-dose Acetylsalicylic Acid (ASA)
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
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)
Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
Secondary prevention of cardiovascular events

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).
Time Frame: Up to 13 years
Up to 13 years
Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.
Time Frame: Up to 13 years
Up to 13 years
Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA
Time Frame: Up to 13 years
Up to 13 years
Time to Intracranial bleeding among new users of low-dose ASA
Time Frame: Up to 13 years
Up to 13 years
Time to Upper gastrointestinal bleeding among new users of low-dose ASA
Time Frame: Up to 13 years
Up to 13 years
Time to Lower gastrointestinal bleeding among new users of low-dose ASA
Time Frame: Up to 13 years
Up to 13 years
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.
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 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.
Up to 13 years
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.
Up to 13 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 13 years
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
Up to 13 years
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
Up to 13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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