Trial record 1 of 1 for:
NCT02550717
Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN) (EPISAT)
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| ClinicalTrials.gov Identifier: NCT02550717 |
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Recruitment Status :
Completed
First Posted : September 15, 2015
Last Update Posted : October 24, 2018
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Brief 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
| Condition or disease | Intervention/treatment |
|---|---|
| Secondary Prevention Stroke Ischemic Heart Disease Coronary Heart Disease | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs |
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.
| Study Type : | Observational |
| Actual Enrollment : | 398158 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| 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 |
| Actual Study Start Date : | September 1, 2015 |
| Actual Primary Completion Date : | March 31, 2017 |
| Actual Study Completion Date : | March 31, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Blood Thinners
Drug Information available for:
Aspirin
| Group/Cohort | Intervention/treatment |
|---|---|
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Acetylsalicylic Acid
New users of low-dose Acetylsalicylic Acid (ASA)
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Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Low-dose ASA for secondary prevention of cardiovascular events |
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Other medications
Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs)
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Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
Secondary prevention of cardiovascular events |
Primary Outcome Measures :
- Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA). [ Time Frame: Up to 13 years ]
- Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA. [ Time Frame: Up to 13 years ]
- Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
- Time to Intracranial bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
- Time to Upper gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
- Time to Lower gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
- Relative risk of Intracranial bleeding among new users of low dose ASA [ Time Frame: Up to 13 years ]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.
- Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]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.
- Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]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.
Secondary Outcome Measures :
- Relative risk of Intracranial bleeding associated with use of other medications. [ Time Frame: Up to 13 years ]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
- Relative risk of Upper gastrointestinal bleeding associated with use of other medications [ Time Frame: Up to 13 years ]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
- Relative risk of Lower gastrointestinal bleeding associated with use of other medications. [ Time Frame: Up to 13 years ]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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 84 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study 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.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550717
Locations
| United Kingdom | |
| Multiple Locations, United Kingdom | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Publications of Results:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT02550717 |
| Other Study ID Numbers: |
18116 |
| First Posted: | September 15, 2015 Key Record Dates |
| Last Update Posted: | October 24, 2018 |
| Last Verified: | October 2018 |
Keywords provided by Bayer:
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Low-dose Acetylsalicylic Acid, Bleeding, The Health Improvement Network (THIN), Cardiovascular Secondary prevention of cardiovascular events |
Additional relevant MeSH terms:
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Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Aspirin Anticoagulants Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |