check_circleStudy Completed

Secondary prevention, Stroke, Ischemic heart disease, Coronary heart disease

Bayer Identifier:

18116

ClinicalTrials.gov Identifier:

NCT02550717

EudraCT Number:

Not Available

EU CT Number:

Not Available
Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

40 - 84 Years
  • - 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

  • - 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 summary

Enrollment Goal
398158
Trial Dates
September 2015 - March 2017
Phase
N/A
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Loactions, United Kingdom

Primary Outcome

  • Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Time to Intracranial bleeding among new users of low-dose ASA
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Time to Upper gastrointestinal bleeding among new users of low-dose ASA
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Time to Lower gastrointestinal bleeding among new users of low-dose ASA
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Up to 13 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A pharmacoepidemiological study on the risk of bleeding in new users of low-dose aspirin (ASA) in The Health Improvement Network (THIN), UK
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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