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

Completed

• Conditions: Ischaemic Heart Disease; Unstable Angina; Myocardial Infarction; Angina; Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack)
• Interventions: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

• Registration Number: NCT04097912
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2019-09-30
• Primary Completion: 2020-11-15
• Study Completion: 2020-11-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99999

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-dose aspirin users	Acetylsalicylic Acid (Aspirin, BAYE4465)	Patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of cardiovascular disease (CVD).

Primary Outcome Measures

Name	Time	Method
Adherence to low-dose aspirin	Retrospective analysis from 2007 to 2018	Adherence low-dose aspirin use will be represented by the medication possession ratio (MPR)
Persistence to low-dose aspirin	Retrospective analysis from 2007 to 2018	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

Secondary Outcome Measures

Name	Time	Method
Time to switch from dual-antiplatelet to a monotherapy	Retrospective analysis from 2007 to 2018

Trial Locations

Locations (1)

Many Locations; 🇬🇧 Multiple Locations, United Kingdom