Trial Condition(s):
Myocardial Infarction, stroke (including ischaemic stroke and transient ischaemic attack), unstable angina, angina, ischaemic heart disease
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)
Bayer Identifier:
20749
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE using OHDSI
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Adherence to low-dose aspirinAdherence low-dose aspirin use will be represented by the medication possession ratio (MPR)Timeframe: Retrospective analysis from 2007 to 2018
- Persistence to low-dose aspirinIn 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 completelyTimeframe: Retrospective analysis from 2007 to 2018
Secondary Outcome
- Time to switch from dual-antiplatelet to a monotherapyTimeframe: Retrospective analysis from 2007 to 2018
Additional Information
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