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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02550717
First Posted: September 15, 2015
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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

Condition Intervention
Secondary Prevention Stroke Ischemic Heart Disease Coronary Heart Disease Drug: Acetylsalicylic Acid (Asprin, BAYE4465) Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: A Pharmacoepidemiologitcal Study on the Risk of Bleeding in New Users of Low-dose Aspirin (ASA) in The Health Improvement Network (THIN), UK

Resource links provided by NLM:


Further study details as provided by Bayer:

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


Enrollment: 398158
Actual Study Start Date: September 1, 2015
Study Completion Date: March 31, 2017
Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acetyl salicylic Acid
New users of low-dose Acetyl salicylic Acid (ASA)
Drug: Acetylsalicylic Acid (Asprin, 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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 84 Years   (Adult, Senior)
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
  Contacts and Locations
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
Many Loactions, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02550717     History of Changes
Other Study ID Numbers: 18116
First Submitted: September 3, 2015
First Posted: September 15, 2015
Last Update Posted: April 12, 2017
Last Verified: April 2017

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
Salicylates
Clopidogrel
Anticoagulants
Salicylic Acid
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