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

NCT ID: NCT04097912

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack) Unstable Angina Angina Ischaemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Low-dose aspirin users

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

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type DRUG

75-100mg

Interventions

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Acetylsalicylic Acid (Aspirin, BAYE4465)

75-100mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many Locations

Multiple Locations, , Germany

Site Status

Many Locations

Multiple Locations, , United Kingdom

Site Status

Countries

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Brazil Italy Germany United Kingdom

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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20749

Identifier Type: -

Identifier Source: org_study_id