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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)

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ClinicalTrials.gov Identifier: NCT04097912
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Myocardial Infarction Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack) Unstable Angina Angina Ischaemic Heart Disease Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

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Study Type : Observational
Estimated 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
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort 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




Primary Outcome Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. Time to switch from dual-antiplatelet to a monotherapy [ Time Frame: Retrospective analysis from 2007 to 2018 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The population included in the study cohort will consist of patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of CVD.

For those being treated with low-dose aspirin for primary CVD prevention, no previous CVD events must have occurred any time prior to initiation of low-dose aspirin treatment. CVD events consist of myocardial infarction, stroke (including ischaemic stroke and transient ischaemic attack), unstable angina, angina, and ischaemic heart disease.

Criteria

Inclusion Criteria:

  • Aged ≥18 years
  • Patients will be selected if they have had a prescription of low-dose aspirin with a dosage of 75-100mg during the study period between 2007 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097912


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Italy
Many locations Not yet recruiting
Multiple Locations, Italy
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04097912     History of Changes
Other Study ID Numbers: 20749
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Heart Diseases
Myocardial Infarction
Angina Pectoris
Myocardial Ischemia
Coronary Artery Disease
Angina, Unstable
Ischemia
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Brain Ischemia
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents