Secondary PreventionEPISATNCT02550717
Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)
An observational study of Secondary Prevention and Stroke, run by Bayer at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Secondary Prevention, Stroke, Ischemic Heart Disease
- What is being tested?
- Acetylsalicylic Acid (Aspirin, BAYE4465) and Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
- Type of treatment
- Pill or oral medicine
- How many people
- 398,158 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2015to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Being tested
- Acetylsalicylic Acid (Aspirin, BAYE4465), Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
- Keywords
- Low-dose Acetylsalicylic Acid,, Bleeding,, The Health Improvement Network (THIN),, Cardiovascular, Secondary prevention of cardiovascular events
- Medical subject headings
- Stroke, Myocardial Ischemia, Coronary Disease, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
Low-dose ASA for secondary prevention of cardiovascular events
Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIsDrug
Secondary prevention of cardiovascular events
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylic Acid | New users of low-dose Acetylsalicylic Acid (ASA) Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) | |
| Other medications | Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs) Receives: Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).
Measured: Up to 13 years
Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.
Measured: Up to 13 years
Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA
Measured: Up to 13 years
Time to Intracranial bleeding among new users of low-dose ASA
Measured: Up to 13 years
Time to Upper gastrointestinal bleeding among new users of low-dose ASA
Measured: Up to 13 years
Time to Lower gastrointestinal bleeding among new users of low-dose ASA
Measured: Up to 13 years
Relative risk of Intracranial bleeding among new users of low dose ASA
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.
Measured: Up to 13 years
Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA
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.
Measured: Up to 13 years
Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA
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.
Measured: Up to 13 years
Secondary outcomes (3)
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 concomitantly
Measured: Up to 13 years
Relative risk of Upper 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 concomitantly
Measured: 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 concomitantly
Measured: Up to 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Secondary PreventionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 398,158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550717
- Sponsor's protocol ID
- 18116
- Acronym
- EPISAT
- Status last verified
- Oct 2018
- First submitted
- 3 Sep 2015
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cea Soriano L, Gaist D, Soriano-Gabarro M, Bromley S, Garcia Rodriguez LA. Low-dose aspirin and risk of intracranial bleeds: An observational study in UK general practice. Neurology. 2017 Nov 28;89(22):2280-2287. doi: 10.1212/WNL.0000000000004694. Epub 2017 Nov 1.
PubMed 29093065Cea Soriano L, Gaist D, Soriano-Gabarro M, Garcia Rodriguez LA. Incidence of intracranial bleeds in new users of low-dose aspirin: a cohort study using The Health Improvement Network. J Thromb Haemost. 2017 Jun;15(6):1055-1064. doi: 10.1111/jth.13686. Epub 2017 May 2.
PubMed 28371181
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02550717
- Acronym / sponsor ID
- EPISAT / 18116
- Keywords
- Low-dose Acetylsalicylic Acid,, Bleeding,, The Health Improvement Network (THIN),, Cardiovascular, Secondary prevention of cardiovascular events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398,158 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylic Acid | – | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)New users of low-dose Acetylsalicylic Acid (ASA) |
| Other medications | – | Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIsUsers of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs) |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAYE4465)Low-dose ASA for secondary prevention of cardiovascular events | Drug | Acetylsalicylic Acid |
| Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIsSecondary prevention of cardiovascular events | Drug | Other medications |
Primary outcome
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.
3 secondary outcomes
Relative risk of Intracranial bleeding associated with use of other medications.
Time frame: Up to 13 years
Relative risk of Upper gastrointestinal bleeding associated with use of other medications
Time frame: Up to 13 years
Relative risk of Lower gastrointestinal bleeding associated with use of other medications.
Time frame: Up to 13 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Results publication: PubMed 29093065Cea Soriano L, Gaist D, Soriano-Gabarro M, Bromley S, Garcia Rodriguez LA. Low-dose aspirin and risk of intracranial bleeds: An observational study in UK general practice. Neurology. 2017 Nov 28;89(22):2280-2287. doi: 10.1212/WNL.0000000000004694. Epub 2017 Nov 1.
- Results publication: PubMed 28371181Cea Soriano L, Gaist D, Soriano-Gabarro M, Garcia Rodriguez LA. Incidence of intracranial bleeds in new users of low-dose aspirin: a cohort study using The Health Improvement Network. J Thromb Haemost. 2017 Jun;15(6):1055-1064. doi: 10.1111/jth.13686. Epub 2017 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Prevention and Stroke, run by Bayer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA). (time frame: Up to 13 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550717, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.