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
PALACE
Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE Using OHDSI
1 other identifier
observational
99,999
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 20, 2019
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2020
CompletedNovember 5, 2021
October 1, 2021
1.1 years
September 19, 2019
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Adherence to low-dose aspirin
Adherence low-dose aspirin use will be represented by the medication possession ratio (MPR)
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
Retrospective analysis from 2007 to 2018
Secondary Outcomes (1)
Time to switch from dual-antiplatelet to a monotherapy
Retrospective analysis from 2007 to 2018
Study Arms (1)
Low-dose aspirin users
Patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of cardiovascular disease (CVD).
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- \- Prescription of low-dose aspirin in 12 months before the index date.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (2)
Many Locations
Multiple Locations, Germany
Many Locations
Multiple Locations, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2019
First Posted
September 20, 2019
Study Start
September 30, 2019
Primary Completion
November 15, 2020
Study Completion
November 15, 2020
Last Updated
November 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.