Trial Condition(s):
Secondary prevention, Stroke, Ischemic heart disease
Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN) (EPISAT)
Bayer Identifier:
18116
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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
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
Trial Summary
Enrollment Goal
398158
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site Many Loactions, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
2
Primary Outcome
- Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).Timeframe: Up to 13 years
- Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.Timeframe: Up to 13 years
- Incidence of Lower gastrointestinal bleeding among new users of low-dose ASATimeframe: Up to 13 years
- Time to Intracranial bleeding among new users of low-dose ASATimeframe: Up to 13 years
- Time to Upper gastrointestinal bleeding among new users of low-dose ASATimeframe: Up to 13 years
- Time to Lower gastrointestinal bleeding among new users of low-dose ASATimeframe: Up to 13 years
- Relative risk of Intracranial bleeding among new users of low dose ASARelative 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.Timeframe: Up to 13 years
- Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASARelative 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.Timeframe: Up to 13 years
- Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASARelative 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.Timeframe: Up to 13 years
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 concomitantlyTimeframe: Up to 13 years
- Relative risk of Upper gastrointestinal bleeding associated with use of other medicationsRelative 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 concomitantlyTimeframe: Up to 13 years
- 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 concomitantlyTimeframe: Up to 13 years
Additional Information
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