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

Completed

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Acetylsalicylic Acid (Asprin, BAYE4465) Drug
    Intervention Desc: Low-dose ASA for secondary prevention of cardiovascular events
    ARM 1: Kind: Experimental
    Label: Acetyl salicylic Acid
    Description: New users of low-dose Acetyl salicylic Acid (ASA)
  • Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs Drug
    Intervention Desc: Secondary prevention of cardiovascular events
    ARM 1: Kind: Experimental
    Label: Other medications
    Description: Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs)

Trial Design

  • Perspective: Retrospective
  • Sampling: Non-Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA) Up to 13 years Yes
Primary Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Time to Intracranial bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Time to Upper gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Time to Lower gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Relative risk of Intracranial bleeding among new users of low dose ASA Up to 13 years Yes
Primary Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Secondary Relative risk of Intracranial bleeding associated with use of other medications Up to 13 years Yes
Secondary Relative risk of Upper gastrointestinal bleeding associated with use of other medications Up to 13 years Yes
Secondary Relative risk of Lower gastrointestinal bleeding associated with use of other medications Up to 13 years Yes
Primary Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA) Up to 13 years Yes
Primary Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Time to Lower gastrointestinal bleeding among new users of low-dose ASA Up to 13 years Yes
Primary Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA). Up to 13 years Yes
Primary Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA. Up to 13 years Yes
Secondary Relative risk of Intracranial bleeding associated with use of other medications. Up to 13 years Yes
Secondary Relative risk of Lower gastrointestinal bleeding associated with use of other medications. Up to 13 years Yes

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