PALACE: 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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT04097912

Collaborator

(none)

99,999

Enrollment

Locations

13.5

Actual Duration (Months)

49999.5

Patients Per Site

3693.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack) Unstable Angina Angina Ischaemic Heart Disease	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Study Design

Study Type:

Observational

Actual Enrollment :

99999 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 30, 2019

Actual Primary Completion Date :

Nov 15, 2020

Actual Study Completion Date :

Nov 15, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Low-dose aspirin users

Patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of cardiovascular disease (CVD).

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

75-100mg

Outcome Measures

Primary Outcome Measures

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

Time to switch from dual-antiplatelet to a monotherapy [Retrospective analysis from 2007 to 2018]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.