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

Myocardial Infarction Clinical Trial

— PALACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097912
• Other study ID #: 20749
• Status: Completed
• Start date: September 30, 2019
• Est. completion date: November 15, 2020

Study information

• Verified date: October 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99999
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina
• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Heart Diseases
• Ischaemic Heart Disease
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Myocardial Infarction
• Myocardial Ischemia
• Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack)
• Unstable Angina

Intervention

Drug:
• Acetylsalicylic Acid (Aspirin, BAYE4465)
75-100mg

Locations

Country	Name	City	State
Germany	Many Locations	Multiple Locations
United Kingdom	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to switch from dual-antiplatelet to a monotherapy		Retrospective analysis from 2007 to 2018

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