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

Stroke Clinical Trial

— EPISAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550717
• Other study ID #: 18116
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: October 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398158
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Secondary Prevention
• Stroke

Intervention

Drug:
• Acetylsalicylic Acid (Aspirin, BAYE4465)
Low-dose ASA for secondary prevention of cardiovascular events
• Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
Secondary prevention of cardiovascular events

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Cea Soriano L, Gaist D, Soriano-Gabarró M, Bromley S, García Rodríguez LA. Low-dose aspirin and risk of intracranial bleeds: An observational study in UK general practice. Neurology. 2017 Nov 28;89(22):2280-2287. doi: 10.1212/WNL.0000000000004694. Epub 20 — View Citation

Cea Soriano L, Gaist D, Soriano-Gabarró M, García Rodríguez LA. Incidence of intracranial bleeds in new users of low-dose aspirin: a cohort study using The Health Improvement Network. J Thromb Haemost. 2017 Jun;15(6):1055-1064. doi: 10.1111/jth.13686. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).		Up to 13 years
Primary	Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.		Up to 13 years
Primary	Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA		Up to 13 years
Primary	Time to Intracranial bleeding among new users of low-dose ASA		Up to 13 years
Primary	Time to Upper gastrointestinal bleeding among new users of low-dose ASA		Up to 13 years
Primary	Time to Lower gastrointestinal bleeding among new users of low-dose ASA		Up to 13 years
Primary	Relative risk of Intracranial bleeding among new users of low dose ASA	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
Primary	Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA	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
Primary	Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA	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	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	Up to 13 years
Secondary	Relative risk of Upper gastrointestinal 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	Up to 13 years
Secondary	Relative risk of Lower gastrointestinal 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	Up to 13 years

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