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

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.

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Key information

Conditions

Myocardial Infarction Angina Angina Pectoris Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischaemic Heart Disease Ischemia Ischemic Attack, Transient Myocardial Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack) Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

75-100mg

Primary outcomes

Adherence to low-dose aspirin

Time frame: 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

Time frame: 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 outcomes

Time to switch from dual-antiplatelet to a monotherapy

Time frame: Retrospective analysis from 2007 to 2018

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: PALACE

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 20, 2019
Registry last updated: Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed