Skip to content

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

Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE Using OHDSI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04097912
Acronym
PALACE
Enrollment
99999
Registered
2019-09-20
Start date
2019-09-30
Completion date
2020-11-15
Last updated
2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack), Unstable Angina, Angina, 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.

Interventions

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adherence to low-dose aspirinRetrospective analysis from 2007 to 2018Adherence low-dose aspirin use will be represented by the medication possession ratio (MPR)
Persistence to low-dose aspirinRetrospective analysis from 2007 to 2018In 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

MeasureTime frame
Time to switch from dual-antiplatelet to a monotherapyRetrospective analysis from 2007 to 2018

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026