Clinical trial NCT02550717: Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Prevention
Stroke
Ischemic Heart Disease
Coronary Heart Disease
Keywords: Low-dose Acetylsalicylic Acid,
Bleeding,
The Health Improvement Network (THIN),
Cardiovascular
Secondary prevention of cardiovascular events
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 398158
Sex: ALL
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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 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

Primary outcomes:
measure: Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).
timeFrame: Up to 13 years
measure: Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.
timeFrame: Up to 13 years
measure: Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA
timeFrame: Up to 13 years
measure: Time to Intracranial bleeding among new users of low-dose ASA
timeFrame: Up to 13 years
measure: Time to Upper gastrointestinal bleeding among new users of low-dose ASA
timeFrame: Up to 13 years
measure: Time to Lower gastrointestinal bleeding among new users of low-dose ASA
timeFrame: Up to 13 years
measure: Relative risk of Intracranial bleeding among new users of low dose ASA
timeFrame: Up to 13 years
measure: Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA
timeFrame: Up to 13 years
measure: Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA
timeFrame: Up to 13 years
Secondary outcomes:
measure: Relative risk of Intracranial bleeding associated with use of other medications.
timeFrame: Up to 13 years
measure: Relative risk of Upper gastrointestinal bleeding associated with use of other medications
timeFrame: Up to 13 years
measure: Relative risk of Lower gastrointestinal bleeding associated with use of other medications.
timeFrame: Up to 13 years
Other outcomes:
Locations:
city: Multiple Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Cea 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.