Myocardial InfarctionPALACENCT04097912
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
An observational study of Myocardial Infarction and Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack), run by Bayer at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack), Unstable Angina
- What is being tested?
- Acetylsalicylic Acid (Aspirin, BAYE4465)
- How many people
- 99,999 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Sep 2019to 15 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Prescription of low-dose aspirin in 12 months before the index date.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE Using OHDSI
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.
- Conditions
- Myocardial Infarction, Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack), Unstable Angina, Angina, Ischaemic Heart Disease
- Being tested
- Acetylsalicylic Acid (Aspirin, BAYE4465)
- Medical subject headings
- Myocardial Infarction, Stroke, Ischemic Attack, Transient, Angina, Unstable, Angina Pectoris, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
75-100mg
| Study group | Role | What they receive |
|---|---|---|
| Low-dose aspirin users | Patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of cardiovascular disease (CVD). Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to low-dose aspirin
Adherence low-dose aspirin use will be represented by the medication possession ratio (MPR)
Measured: Retrospective analysis from 2007 to 2018
Persistence to low-dose aspirin
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
Measured: Retrospective analysis from 2007 to 2018
Secondary outcomes (1)
Time to switch from dual-antiplatelet to a monotherapy
Measured: Retrospective analysis from 2007 to 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start30 Sep 2019
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097912
- Sponsor's protocol ID
- 20749
- Acronym
- PALACE
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2019
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence and Adherence to Low-Dose Aspirin for Primary and Secondary Prevention of Cardiovascular DiseasE Using OHDSI
- ClinicalTrials.gov ID
- NCT04097912
- Acronym / sponsor ID
- PALACE / 20749
- Conditions
- Myocardial Infarction, Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack), Unstable Angina, Angina, Ischaemic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,999 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose aspirin users | – | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)Patients who receive low-dose aspirin (75-100mg) for either the primary or secondary prevention of cardiovascular disease (CVD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- Prescription of low-dose aspirin in 12 months before the index date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAYE4465)75-100mg | Drug | Low-dose aspirin users |
Primary outcome
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
1 secondary outcome
Time to switch from dual-antiplatelet to a monotherapy
Time frame: Retrospective analysis from 2007 to 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No. Availability of this study's data will later 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Stroke (Including Ischaemic Stroke and Transient Ischaemic Attack), run by Bayer at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to low-dose aspirin (time frame: Retrospective analysis from 2007 to 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.