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

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ClinicalTrials.gov Identifier: NCT02550717
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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.

Study Type : Observational
Actual Enrollment : 398158 participants
Observational Model: Other
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
Acetylsalicylic Acid
New users of low-dose Acetylsalicylic Acid (ASA)
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Low-dose ASA for secondary prevention of cardiovascular events

Other medications
Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs)
Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
Secondary prevention of cardiovascular events




Primary Outcome Measures :
  1. Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA). [ Time Frame: Up to 13 years ]
  2. Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA. [ Time Frame: Up to 13 years ]
  3. Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
  4. Time to Intracranial bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
  5. Time to Upper gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
  6. Time to Lower gastrointestinal bleeding among new users of low-dose ASA [ Time Frame: Up to 13 years ]
  7. 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.

  8. 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.

  9. 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 :
  1. 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

  2. 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

  3. 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



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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

Additional Information:
Publications of Results:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02550717     History of Changes
Other Study ID Numbers: 18116
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Bayer:
Low-dose Acetylsalicylic Acid,
Bleeding,
The Health Improvement Network (THIN),
Cardiovascular
Secondary prevention of cardiovascular events

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Clopidogrel
Anticoagulants
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