Clinical trial NCT04097912: Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Official title: Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE Using OHDSI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack)
Unstable Angina
Angina
Ischaemic Heart Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 99999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population included in the study cohort will consist of patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of CVD.

For those being treated with low-dose aspirin for primary CVD prevention, no previous CVD events must have occurred any time prior to initiation of low-dose aspirin treatment. CVD events consist of myocardial infarction, stroke (including ischaemic stroke and transient ischaemic attack), unstable angina, angina, and ischaemic heart disease.

Brief summary: This study aims to gather information to what extent patients follow the treatment regimen of low-dose aspirin for primary and secondary prevention of diseases of the heart and blood vessels. Researcher will collect information about the percentage of time a patient has access to the medication, how long patients continue with the medication and of the proportion of patients who switch from dual-antiplatelet therapy (including low-dose aspirin) to a single antiplatelet therapy. The study will make use of secondary healthcare data sources converted in to Observational Medical Outcomes Partnership (OMOP) common data model within the Observational Health Data Sciences and Informatics (OHDSI) network.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* Patients will be selected if they have at least two prescriptions for low-dose aspirin (75-100 mg) between 2008 and 2018 for either:

  * Primary prevention of CVD This is defined as patients who have no history of CVD any time prior to initiation of low-dose aspirin treatment are presumed to use for primary CVD prevention
  * Secondary prevention of CVD This is defined as patients who have a history of CVD any time prior to initiation of low-dose aspirin treatment
* Patients with at least two prescriptions of low-dose aspirin with a dosage of 75-100mg within the first year of the index date.
* Restricted to patients with observation for at least 12 months before and 12 after the index date.

Exclusion Criteria:

- Prescription of low-dose aspirin in 12 months before the index date.

Primary outcomes:
measure: Adherence to low-dose aspirin
timeFrame: Retrospective analysis from 2007 to 2018
measure: Persistence to low-dose aspirin
timeFrame: Retrospective analysis from 2007 to 2018
Secondary outcomes:
measure: Time to switch from dual-antiplatelet to a monotherapy
timeFrame: Retrospective analysis from 2007 to 2018
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many Locations
city: Multiple Locations
country: United Kingdom
facility: Many Locations
Study officials:
References: