check_circleStudy Completed
Secondary prevention, Stroke, Ischemic heart disease, Coronary heart disease
Bayer Identifier:
18116
ClinicalTrials.gov Identifier:
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
BothAge
40 - 84 YearsTrial summary
Enrollment Goal
398158Trial Dates
September 2015 - March 2017Phase
N/ACould I Receive a placebo
NoProducts
Aspirin (Acetylsalicylic Acid, BAYE4465)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 yearsenhanced_encryptionYesSafety Issue:
- Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.date_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- Incidence of Lower gastrointestinal bleeding among new users of low-dose ASAdate_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- Time to Intracranial bleeding among new users of low-dose ASAdate_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- Time to Upper gastrointestinal bleeding among new users of low-dose ASAdate_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- Time to Lower gastrointestinal bleeding among new users of low-dose ASAdate_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- 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.date_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- 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.date_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- 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.date_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
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 concomitantlydate_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- 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 concomitantlydate_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
- 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 concomitantlydate_rangeTime Frame:Up to 13 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A