Prevention of Thromboembolic EventsNCT05471830
An Observational Study (Called RETAF-PS) Using a Patient Survey to Learn More About Treatment Outcomes in Patients With Irregular and Often Rapid Heartbeat (Atrial Fibrillation) Treated With Apixaban in a Real World Setting
An observational study of Prevention of Thromboembolic Events and Atrial Fibrillation, run by Bayer at 1 site in United States.
Trial summary
This is an observational study in which data from people with atrial fibrillation who received or are currently receiving the drug apixaban to prevent thromboembolic events (blood clots that travel through the blood stream to plug another smaller vessel) are studied. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Prevention of Thromboembolic Events, Atrial Fibrillation
- What is being tested?
- Apixaban
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to 1 Dec 2023
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of survey-eligible, current health plan members with Commercial or Medicare Advantage health insurance who have at least one medical claim with an international classification of disease, 10th revision (ICD-10) diagnosis code for AF and at least one pharmacy claim for apixaban in the HealthCore Integrated Research Database (HIRD). The HIRD will be used as a sampling frame to identify a purposive sample of survey-eligible patients.
Who may be able to join
- Patients with Commercial or Medicare Advantage health insurance (both medical and pharmacy benefits) during the patient identification period (most recent 12-months of HIRD claims data at the time the patient sample is identified and extracted).
- Age ≥45 years at the end of the patient identification period.
- At least one medical claim with an ICD-10-CM diagnosis code of AF during the patient identification period.
- At least one pharmacy claim for apixaban during the patient identification period; the date of the most recent pharmacy claim will be the patient sample claims index date.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REal-World Treatment Outcomes of Oral-Anticoagulants Among Patients With Atrial Fibrillation - Patient Survey - RETAF-PS
This is an observational study in which data from people with atrial fibrillation who received or are currently receiving the drug apixaban to prevent thromboembolic events (blood clots that travel through the blood stream to plug another smaller vessel) are studied. In observational studies, only observations are made without specified advice or interventions.
Atrial Fibrillation (AF) is a condition of having irregular and often rapid heartbeat. AF can lead to the formation of blood clots in the heart and to embolism, a condition that happens when a blood clot travels through the blood stream to plug another smaller vessel. This can lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from AF can involve extensive areas of the brain, it is important to prevent them.
Read more
Blood clots are formed in a process known as coagulation. This is a complex series of steps that must occur in a specific sequence.
Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs). OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding.
In the beginning, there was only one main class of OAC called vitamin k antagonists (VKAs) prescribed in usual practice. VKAs work by lowering the number of coagulation factors in the blood. Over the years, newer OAC medications have become available which act more specifically by interrupting one or more of the coagulation steps and preventing the blood from clotting. The study treatment apixaban works by blocking a very specific step in the blood clotting process, the activation of a protein called Factor Xa. Newer OACs are also called direct oral anticoagulants (DOACs). DOACs require less monitoring by doctors, but an increased risk of bleeding remains.
Bleedings can be an important reason for stopping therapy. One type of bleeding called patient relevant bleeding (PRB) has not been intensely studied so far. PRB is a type of minor bleeding which is bothersome, but which does not require medical treatment as it has no important impact on a person's health.
It needs to be distinguished from so called clinically relevant non-major bleeding (CRNMB). CRNMB stands for a type of bleeding which may have an important impact on a person's health and needs medical attention, but when treated, is not likely to have a negative impact on a person's health.
Only limited information is available for PRB and CRNMB related to the treatment with DOACs in real-world settings.
In this study, researchers want to collect more data about how often PRB and CRNMB occur in people with AF treated with apixaban. In addition, researchers want to learn how these medical problems affect the treatment with apixaban under real-world conditions. To do this, researchers will count the number of participants in usual practice
- who have PRB or CRNMB and who are being treated with apixaban at the time of this ongoing study or who have recently taken this drug, but have switched to another OAC,
- who have PRB or CRNMB and have decided to stop or to continue their treatment with apixaban.
In addition, characteristics of each participant and the reason for continuation or discontinuation of apixaban will be collected and described. The data for this study will come from patient surveys.
Besides this data collection, no further tests or examinations are planned in this study.
The participants who take their apixaban treatment during this study will receive their treatments as prescribed by their doctors during routine practice according to the approved product information.
The data will be from participants who will be identified for the survey using last 12-months data from the database called HealthCore Integrated Research Database (HIRD). The data will be collected for each participant for 12 months before the participant starts the survey. The study will end as soon as the planned number of surveys has been reached or at the end date of the study.
- Being tested
- Apixaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
No drug will be provided to participants. Patients follow routine clinical practice/administration.
| Study group | Role | What they receive |
|---|---|---|
| Patient survey | Survey-eligible patients with Commercial or Medicare Advantage health insurance who are current/past users of sMRA therapies and diagnosed with chronic kidney disease (CKD), type 2 diabetes (T2D) or heart failure (HF). Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation history
Measured: Up to 12 months
The occurrence of PRB and CRNMB events and if bleeding was the reason for skipping doses, temporarily pausing, or completely stopping, or changing dose, or switch to other treatment (if occurred)
The questions are designed for participants who are current users of apixaban.
PRB stands for patient relevant bleeding. CRNMB stands for clinically relevant non-major bleed.
Measured: Up to 12 months
The occurrence of PRB and CRNMB events and if bleeding(s) were reasons for skipped doses, temporarily paused or completely stopped (if occurred) apixaban therapy
The questions are designed for participants who have discontinued apixaban.
Measured: Up to 12 months
Claims-based descriptive analysis of patient demographics characteristics
Measured: Up to 12 months
Claims-based descriptive analysis of patient clinical characteristics
Measured: Up to 12 months
The occurrence of stroke events during the 12 months prior to the survey date
Measured: Up to 12 months
Secondary outcomes (5)
Patient perceptions regarding anticoagulation therapy
Questions for patients who are never on apixaban but current or past use of other anticoagulant questions
Measured: Up to 12 months
Patient perceptions on risk of stroke and bleeding and reasons for not initiated an anticoagulant medication
Questions for participants who were never on anticoagulant treatments
Measured: Up to 12 months
Number of days the participants had apixaban on-hand during the time period between the first prescription within the last 12 months and the survey date (Apixaban adherence)
Measured: Up to 12 months
Number of participants who did not have a break in apixaban therapy during the period of time between the first prescription within the last 12-month from the survey date and the survey date (Apixaban persistence)
Measured: Up to 12 months
Number of physician office visits during the 12 months prior to the survey date
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start30 Nov 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Thromboembolic EventsStudies 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
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471830
- Sponsor's protocol ID
- 22155
- Status last verified
- Dec 2023
- First submitted
- 21 Jul 2022
- Last updated
- 12 Dec 2023
- 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-World Treatment Outcomes of Oral-Anticoagulants Among Patients With Atrial Fibrillation - Patient Survey - RETAF-PS
- ClinicalTrials.gov ID
- NCT05471830
- Acronym / sponsor ID
- 22155
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 25 Jul 2022 (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 is an observational study in which data from people with atrial fibrillation who received or are currently receiving the drug apixaban to prevent thromboembolic events (blood clots that travel through the blood stream to plug another smaller vessel) are studied. In observational studies, only observations are made without specified advice or interventions.
Atrial Fibrillation (AF) is a condition of having irregular and often rapid heartbeat. AF can lead to the formation of blood clots in the heart and to embolism, a condition that happens when a blood clot travels through the blood stream to plug another smaller vessel. This can lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from AF can involve extensive areas of the brain, it is important to prevent them.
Blood clots are formed in a process known as coagulation. This is a complex series of steps that must occur in a specific sequence.
Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs). OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding.
In the beginning, there was only one main class of OAC called vitamin k antagonists (VKAs) prescribed in usual practice. VKAs work by lowering the number of coagulation factors in the blood. Over the years, newer OAC medications have become available which act more specifically by interrupting one or more of the coagulation steps and preventing the blood from clotting. The study treatment apixaban works by blocking a very specific step in the blood clotting process, the activation of a protein called Factor Xa. Newer OACs are also called direct oral anticoagulants (DOACs). DOACs require less monitoring by doctors, but an increased risk of bleeding remains.
Bleedings can be an important reason for stopping therapy. One type of bleeding called patient relevant bleeding (PRB) has not been intensely studied so far. PRB is a type of minor bleeding which is bothersome, but which does not require medical treatment as it has no important impact on a person's health.
It needs to be distinguished from so called clinically relevant non-major bleeding (CRNMB). CRNMB stands for a type of bleeding which may have an important impact on a person's health and needs medical attention, but when treated, is not likely to have a negative impact on a person's health.
Only limited information is available for PRB and CRNMB related to the treatment with DOACs in real-world settings.
In this study, researchers want to collect more data about how often PRB and CRNMB occur in people with AF treated with apixaban. In addition, researchers want to learn how these medical problems affect the treatment with apixaban under real-world conditions. To do this, researchers will count the number of participants in usual practice
- who have PRB or CRNMB and who are being treated with apixaban at the time of this ongoing study or who have recently taken this drug, but have switched to another OAC,
- who have PRB or CRNMB and have decided to stop or to continue their treatment with apixaban.
In addition, characteristics of each participant and the reason for continuation or discontinuation of apixaban will be collected and described. The data for this study will come from patient surveys.
Besides this data collection, no further tests or examinations are planned in this study.
The participants who take their apixaban treatment during this study will receive their treatments as prescribed by their doctors during routine practice according to the approved product information.
The data will be from participants who will be identified for the survey using last 12-months data from the database called HealthCore Integrated Research Database (HIRD). The data will be collected for each participant for 12 months before the participant starts the survey. The study will end as soon as the planned number of surveys has been reached or at the end date of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient survey | – | Drug: ApixabanSurvey-eligible patients with Commercial or Medicare Advantage health insurance who are current/past users of sMRA therapies and diagnosed with chronic kidney disease (CKD), type 2 diabetes (T2D) or heart failure (HF). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of survey-eligible, current health plan members with Commercial or Medicare Advantage health insurance who have at least one medical claim with an international classification of disease, 10th revision (ICD-10) diagnosis code for AF and at least one pharmacy claim for apixaban in the HealthCore Integrated Research Database (HIRD). The HIRD will be used as a sampling frame to identify a purposive sample of survey-eligible patients.
Key inclusion criteria (4 listed)
- Patients with Commercial or Medicare Advantage health insurance (both medical and pharmacy benefits) during the patient identification period (most recent 12-months of HIRD claims data at the time the patient sample is identified and extracted).
- Age ≥45 years at the end of the patient identification period.
- At least one medical claim with an ICD-10-CM diagnosis code of AF during the patient identification period.
- At least one pharmacy claim for apixaban during the patient identification period; the date of the most recent pharmacy claim will be the patient sample claims index date.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ApixabanNo drug will be provided to participants. Patients follow routine clinical practice/administration. | Drug | Patient survey |
Primary outcome
Atrial fibrillation history
Time frame: Up to 12 months
The occurrence of PRB and CRNMB events and if bleeding was the reason for skipping doses, temporarily pausing, or completely stopping, or changing dose, or switch to other treatment (if occurred)
Time frame: Up to 12 months
The questions are designed for participants who are current users of apixaban. PRB stands for patient relevant bleeding. CRNMB stands for clinically relevant non-major bleed.
The occurrence of PRB and CRNMB events and if bleeding(s) were reasons for skipped doses, temporarily paused or completely stopped (if occurred) apixaban therapy
Time frame: Up to 12 months
The questions are designed for participants who have discontinued apixaban.
Claims-based descriptive analysis of patient demographics characteristics
Time frame: Up to 12 months
Claims-based descriptive analysis of patient clinical characteristics
Time frame: Up to 12 months
The occurrence of stroke events during the 12 months prior to the survey date
Time frame: Up to 12 months
5 secondary outcomes
Patient perceptions regarding anticoagulation therapy
Time frame: Up to 12 months
Patient perceptions on risk of stroke and bleeding and reasons for not initiated an anticoagulant medication
Time frame: Up to 12 months
Number of days the participants had apixaban on-hand during the time period between the first prescription within the last 12 months and the survey date (Apixaban adherence)
Time frame: Up to 12 months
Number of participants who did not have a break in apixaban therapy during the period of time between the first prescription within the last 12-month from the survey date and the survey date (Apixaban persistence)
Time frame: Up to 12 months
Number of physician office visits during the 12 months prior to the survey date
Time frame: Up to 12 months
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 12 Dec 2023.
- 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.vivli.org 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 member 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Thromboembolic Events and Atrial Fibrillation, run by Bayer at 1 site in United States.
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 4 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Atrial fibrillation history (time frame: Up to 12 months). The study lists 6 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 12 Dec 2023.