check_circleStudy Completed

myocardial infarction, stroke (including ischaemic stroke and transient ischaemic attack), unstable angina, angina, ischaemic heart disease

Bayer Identifier:

20749

ClinicalTrials.gov Identifier:

NCT04097912

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - Prescription of low-dose aspirin in 12 months before the index date.

Trial summary

Enrollment Goal
99999
Trial Dates
September 2019 - November 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Many LocationsMany Locations, Italy
Withdrawn
Many LocationsMany Locations, Brazil
Completed
Many LocationsMany Locations, Germany
Completed
Many LocationsMany Locations, United Kingdom

Primary Outcome

  • Adherence to low-dose aspirin
    Adherence low-dose aspirin use will be represented by the medication possession ratio (MPR)
    date_rangeTime Frame:
    Retrospective analysis from 2007 to 2018
  • Persistence to low-dose aspirin
    In terms of continuation and discontinuation: - Continuation at 30 and 60 day gaps - Discontinuation: - If patients switched to another antiplatelet therapy - If patients reinitiated low-dose aspirin >30 days and >60 days after end of supply i.e. of the pre-specified gap was exceeded - If patients stopped low-dose aspirin therapy completely
    date_rangeTime Frame:
    Retrospective analysis from 2007 to 2018

Secondary Outcome

  • Time to switch from dual-antiplatelet to a monotherapy
    date_rangeTime Frame:
    Retrospective analysis from 2007 to 2018

Trial design

Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE using OHDSI
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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