Atrial Fibrillation on Apixaban TreatmentNCT06869083
Application-Delivered Patient Education in Enhancing the Usage of Apixaban in Patients With Atrial Fibrillation
A study testing AF application enhancing AF education and drug adhrence and AF application without enhancing AF education and drug adhrence in people with Atrial Fibrillation on Apixaban Treatment, run by Yonsei University at 1 site in South Korea.
Trial summary
"AF is the most common arrhythmia, with an overall prevalence of approximately 2%. It is particularly prevalent in individuals over 60 years old, affecting about 5% of this population. With the aging population, the global prevalence of AF is increasing. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Atrial Fibrillation on Apixaban Treatment
- What is being tested?
- AF application enhancing AF education and drug adhrence and AF application without enhancing AF education and drug adhrence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2025to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older with non-valvular atrial fibrillation (NVAF).
- Willingness to provide informed consent and participate in the study.
- Receiving Elxaban as anticoagulation therapy.
- Ability to use the mobile application.
Who cannot join
- Inability to understand the study or refusal to provide consent.
- Minors under 19 years of age.
- Pregnant or breastfeeding women.
- Conditions requiring chronic anticoagulation therapy other than atrial fibrillation (e.g., mechanical heart valve replacement).
- Life expectancy of less than one year due to severe comorbid conditions.
- Contraindications to Elxaban use, including:
Show all 19Show fewer
- Hypersensitivity to the active ingredient or any excipients of the drug.
- Severe renal impairment (CrCL <15 mL/min).
- Clinically significant active bleeding.
- Increased bleeding risk due to the following conditions:
- Recent history of gastrointestinal ulcer.
- High-risk malignant neoplasms.
- Recent brain or spinal cord injury.
- Recent history of brain, spinal, or ophthalmic surgery.
- Recent history of intracranial or cerebral hemorrhage.
- Suspected or confirmed esophageal varices.
- Arteriovenous malformations.
- Vascular aneurysms.
- Spinal or intracranial vascular abnormalities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
Official title: Application-Delivered Patient Education in Enhancing the Usage of Apixaban in Patients With Atrial Fibrillation: Randomized Control Therapy
"AF is the most common arrhythmia, with an overall prevalence of approximately 2%. It is particularly prevalent in individuals over 60 years old, affecting about 5% of this population. With the aging population, the global prevalence of AF is increasing. In South Korea, the overall prevalence of AF increased from 0.73% in 2006 to 1.53% in 2015, a 2.1-fold increase. By 2060, it is projected that 2.3 million people in Korea will have AF, with a prevalence rate of 5.81%. AF accounts for approximately 20% of all ischemic strokes, and patients with AF have an annual risk of ischemic stroke ranging from 6% to 10%. Additionally, AF can lead to heart failure and doubles the mortality rate. Despite various treatment options, the mortality rate associated with AF continues to rise annually.
Anticoagulation therapy for the prevention of thromboembolism in AF is a crucial treatment approach. Traditional warfarin therapy has been shown to reduce the risk of stroke by approximately 63%. Recently developed non-vitamin K oral anticoagulants (NOACs) have demonstrated similar efficacy to warfarin while offering a lower risk of hemorrhagic complications, particularly intracranial hemorrhage, making them a safer alternative.
Read more
Adherence to anticoagulant therapy is crucial for the effective prevention of stroke in patients with AF. Poor adherence to anticoagulants significantly increases the risk of thromboembolic events, including ischemic stroke. Studies have shown that patients with low adherence to anticoagulation therapy experience higher rates of stroke and mortality compared to those who consistently take their medication as prescribed. Ensuring proper adherence to anticoagulants, whether traditional warfarin or newer non-vitamin K oral anticoagulants (NOACs), is essential to maximizing treatment benefits while minimizing complications. Factors influencing adherence include medication side effects, complexity of the treatment regimen, patient awareness, and regular follow-up with healthcare providers. Strategies to improve adherence, such as patient education, simplified dosing regimens, and routine monitoring, play a key role in reducing the burden of AF-related strokes.
The burden of cardiovascular risk factors, including lifestyle factors and borderline conditions, as well as comorbidities, significantly influences both the risk of AF development and its prognosis. The continuum of unhealthy lifestyle habits, risk factors, and cardiovascular diseases contributes to atrial remodeling, cardiomyopathy, and ultimately, the onset of AF through the combined effects of multiple interacting factors. One of the three core components of the Atrial Fibrillation Better Care (ABC) pathway for comprehensive AF management is the ""C"" component, which focuses on the identification and management of comorbidities, cardiometabolic risk factors, and unhealthy lifestyle habits. Effective management of these risk factors and cardiovascular diseases plays a crucial role in stroke prevention and in reducing AF burden and symptom severity. Recent randomized clinical trials have shown that targeted treatment of underlying conditions improves the maintenance of sinus rhythm following AF ablation in patients with persistent AF and heart failure.
Education by healthcare providers regarding medication adherence and risk factor management for existing AF patients is often limited due to constraints in manpower and resources. However, leveraging new technologies such as mobile applications can help overcome these limitations by enhancing patient education and improving medication adherence without the need for additional healthcare personnel.
This study is fundamentally a prospective, multicenter, randomized, open-label clinical trial. Patients with atrial fibrillation who are prescribed edoxaban at participating institutions will be randomly assigned to either an app-based anticoagulation education group or a non-education group. Primary objective is to demonstrate that an app-based education program for patients with AF taking apixaban results in a lower incidence of major cardiovascular events (ischemic stroke/systemic embolism, major bleeding, hospitalization, myocardial infarction, and death) compared to the non-education group. Secondary Objective is to investigate the impact of the intervention on secondary events, including stroke, systemic embolism, transient ischemic attack (TIA), major bleeding, non-major bleeding, hospitalization, myocardial infarction, death, and medication adherence. Exploratory Objective are to assess treatment satisfaction using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire, and to evaluate cognitive function changes using the Korean Dementia Screening Questionnaire (KDSQ).
Read the detailed description
"This study is fundamentally a prospective, multicenter, randomized, open-label clinical trial. Patients with AF receiving apixaban at participating institutions will be randomly assigned to either an app-based anticoagulation education group or a non-education group. The incidence rates of primary, secondary, and exploratory events will be assessed.
The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires.
Follow-up assessments will be conducted every six months after enrollment. The anticipated enrollment period is four years, with a minimum follow-up duration of one year.
Participants will have voluntary access to educational materials in the app. Medication adherence will be encouraged through reminder alarms, while other educational components will not have specific evaluation methods. The study investigator is responsible for developing the medication adherence education app. The app's content is currently being finalized, and development will be completed using research funding after study approval.
Randomization will be conducted using an Excel macro function, assigning participants in a 1:1 ratio. The randomization process will be uploaded to iCReaT, an electronic case report form (eCRF) system, allowing verification at the time of participant registration.
Primary Outcome: The primary composite outcome consists of ischemic stroke, intracranial hemorrhage, and myocardial infarction. This outcome was selected based on previous domestic studies demonstrating that medication adherence reduces the incidence of these composite events. Evaluations will be conducted every six months after enrollment. The anticipated enrollment period is four years, with a minimum follow-up duration of one year.
Secondary Outcomes: The study will assess the following secondary outcomes: Stroke (ischemic and hemorrhagic), Transient ischemic attack (TIA), Systemic embolism, Major bleeding, Non-major bleeding, Myocardial infarction, Death, Hospitalization events, and Medication adherence. Evaluations will be conducted every six months after enrollment. The anticipated enrollment period is four years, with a minimum follow-up duration of one year.
"
- Being tested
- AF application enhancing AF education and drug adhrence, AF application without enhancing AF education and drug adhrence
- Keywords
- atrial fibrillation, apixaban, anticoagulation, adherence, application, eduction
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF application enhancing AF education and drug adhrenceOther
This group will use AF-application. The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires.
AF application without enhancing AF education and drug adhrenceOther
This group will use AF-application. However, this application will not contain materials enhancing AF education and adherence.
| Study group | Role | What they receive |
|---|---|---|
| App education group | Experimental | Not described Receives: Other: AF application enhancing AF education and drug adhrence |
| No-App education group | Active comparator | Not described Receives: Other: AF application without enhancing AF education and drug adhrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary composite outcome
The primary composite outcome consists of ischemic stroke, intracranial hemorrhage, and myocardial infarction.
Measured: every 6 month up to 4 years until the end of study, with a minum follow-up duration of one year.
Secondary outcomes (18)
Secondary end points assessed time to stroke (ischemic and hemorrhagic)
Measured: every 6 month up to 4 years until the end of study
transient ischemic attack (TIA)
Measured: every 6 month up to 4 years until the end of study
systemic embolism
Measured: every 6 month up to 4 years until the end of study
major bleeding
Major bleeding was defined according to the criteria of International Society on Thrombosis and Haemostasis (ISTH).
Measured: every 6 month up to 4 years until the end of study
clinically relevant non-major bleeding
Clinically relevant non-major bleeding define a bleeding event that is neither a major bleed as defined by the ISTH 1 nor a non-clinically consequential minor bleeding event.
Measured: every 6 month up to 4 years until the end of study
myocardial infarction
Measured: every 6 month up to 4 years until the end of study
death
Measured: every 6 month up to 4 years until the end of study
hospitalization events
Measured: every 6 month up to 4 years until the end of study
medication adherence
Medication adherence is defined as the percentage of the prescribed doses of the medication actually taken by the patient over a follow-up duration.
Measured: every 6 month up to 4 years until the end of study
Secondary end points assessed time to stroke (ischemic and hemorrhagic)
Measured: a minum follow-up duration of one year.
transient ischemic attack (TIA)
Measured: a minum follow-up duration of one year.
systemic embolism
Measured: a minum follow-up duration of one year.
major bleeding
Major bleeding was defined according to the criteria of International Society on Thrombosis and Haemostasis (ISTH).
Measured: a minum follow-up duration of one year.
clinically relevant non-major bleeding
Clinically relevant non-major bleeding define a bleeding event that is neither a major bleed as defined by the ISTH 1 nor a non-clinically consequential minor bleeding event.
Measured: a minum follow-up duration of one year.
myocardial infarction
Measured: a minum follow-up duration of one year.
death
Measured: a minum follow-up duration of one year.
hospitalization events
Measured: a minum follow-up duration of one year.
medication adherence
Medication adherence is defined as the percentage of the prescribed doses of the medication actually taken by the patient over a follow-up duration.
Measured: a minum follow-up duration of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startMar 2025 (estimated)
- Primary completion28 Feb 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation on Apixaban TreatmentStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869083
- Sponsor's protocol ID
- 4-2024-1210
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application-Delivered Patient Education in Enhancing the Usage of Apixaban in Patients With Atrial Fibrillation: Randomized Control Therapy
- ClinicalTrials.gov ID
- NCT06869083
- Acronym / sponsor ID
- 4-2024-1210
- Keywords
- atrial fibrillation, apixaban, anticoagulation, adherence, application, eduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 11 Mar 2025 (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.
"AF is the most common arrhythmia, with an overall prevalence of approximately 2%. It is particularly prevalent in individuals over 60 years old, affecting about 5% of this population. With the aging population, the global prevalence of AF is increasing. In South Korea, the overall prevalence of AF increased from 0.73% in 2006 to 1.53% in 2015, a 2.1-fold increase. By 2060, it is projected that 2.3 million people in Korea will have AF, with a prevalence rate of 5.81%. AF accounts for approximately 20% of all ischemic strokes, and patients with AF have an annual risk of ischemic stroke ranging from 6% to 10%. Additionally, AF can lead to heart failure and doubles the mortality rate. Despite various treatment options, the mortality rate associated with AF continues to rise annually.
Anticoagulation therapy for the prevention of thromboembolism in AF is a crucial treatment approach. Traditional warfarin therapy has been shown to reduce the risk of stroke by approximately 63%. Recently developed non-vitamin K oral anticoagulants (NOACs) have demonstrated similar efficacy to warfarin while offering a lower risk of hemorrhagic complications, particularly intracranial hemorrhage, making them a safer alternative.
Adherence to anticoagulant therapy is crucial for the effective prevention of stroke in patients with AF. Poor adherence to anticoagulants significantly increases the risk of thromboembolic events, including ischemic stroke. Studies have shown that patients with low adherence to anticoagulation therapy experience higher rates of stroke and mortality compared to those who consistently take their medication as prescribed. Ensuring proper adherence to anticoagulants, whether traditional warfarin or newer non-vitamin K oral anticoagulants (NOACs), is essential to maximizing treatment benefits while minimizing complications. Factors influencing adherence include medication side effects, complexity of the treatment regimen, patient awareness, and regular follow-up with healthcare providers. Strategies to improve adherence, such as patient education, simplified dosing regimens, and routine monitoring, play a key role in reducing the burden of AF-related strokes.
The burden of cardiovascular risk factors, including lifestyle factors and borderline conditions, as well as comorbidities, significantly influences both the risk of AF development and its prognosis. The continuum of unhealthy lifestyle habits, risk factors, and cardiovascular diseases contributes to atrial remodeling, cardiomyopathy, and ultimately, the onset of AF through the combined effects of multiple interacting factors. One of the three core components of the Atrial Fibrillation Better Care (ABC) pathway for comprehensive AF management is the ""C"" component, which focuses on the identification and management of comorbidities, cardiometabolic risk factors, and unhealthy lifestyle habits. Effective management of these risk factors and cardiovascular diseases plays a crucial role in stroke prevention and in reducing AF burden and symptom severity. Recent randomized clinical trials have shown that targeted treatment of underlying conditions improves the maintenance of sinus rhythm following AF ablation in patients with persistent AF and heart failure.
Education by healthcare providers regarding medication adherence and risk factor management for existing AF patients is often limited due to constraints in manpower and resources. However, leveraging new technologies such as mobile applications can help overcome these limitations by enhancing patient education and improving medication adherence without the need for additional healthcare personnel.
This study is fundamentally a prospective, multicenter, randomized, open-label clinical trial. Patients with atrial fibrillation who are prescribed edoxaban at participating institutions will be randomly assigned to either an app-based anticoagulation education group or a non-education group. Primary objective is to demonstrate that an app-based education program for patients with AF taking apixaban results in a lower incidence of major cardiovascular events (ischemic stroke/systemic embolism, major bleeding, hospitalization, myocardial infarction, and death) compared to the non-education group. Secondary Objective is to investigate the impact of the intervention on secondary events, including stroke, systemic embolism, transient ischemic attack (TIA), major bleeding, non-major bleeding, hospitalization, myocardial infarction, death, and medication adherence. Exploratory Objective are to assess treatment satisfaction using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire, and to evaluate cognitive function changes using the Korean Dementia Screening Questionnaire (KDSQ).
Detailed description
"This study is fundamentally a prospective, multicenter, randomized, open-label clinical trial. Patients with AF receiving apixaban at participating institutions will be randomly assigned to either an app-based anticoagulation education group or a non-education group. The incidence rates of primary, secondary, and exploratory events will be assessed.
The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires.
Follow-up assessments will be conducted every six months after enrollment. The anticipated enrollment period is four years, with a minimum follow-up duration of one year.
Participants will have voluntary access to educational materials in the app. Medication adherence will be encouraged through reminder alarms, while other educational components will not have specific evaluation methods. The study investigator is responsible for developing the medication adherence education app. The app's content is currently being finalized, and development will be completed using research funding after study approval.
Randomization will be conducted using an Excel macro function, assigning participants in a 1:1 ratio. The randomization process will be uploaded to iCReaT, an electronic case report form (eCRF) system, allowing verification at the time of participant registration.
Primary Outcome: The primary composite outcome consists of ischemic stroke, intracranial hemorrhage, and myocardial infarction. This outcome was selected based on previous domestic studies demonstrating that medication adherence reduces the incidence of these composite events. Evaluations will be conducted every six months after enrollment. The anticipated enrollment period is four years, with a minimum follow-up duration of one year.
Secondary Outcomes: The study will assess the following secondary outcomes: Stroke (ischemic and hemorrhagic), Transient ischemic attack (TIA), Systemic embolism, Major bleeding, Non-major bleeding, Myocardial infarction, Death, Hospitalization events, and Medication adherence. Evaluations will be conducted every six months after enrollment. The anticipated enrollment period is four years, with a minimum follow-up duration of one year.
"
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App education group | Experimental | Other: AF application enhancing AF education and drug adhrence |
| No-App education group | Active comparator | Other: AF application without enhancing AF education and drug adhrence |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 19 years or older with non-valvular atrial fibrillation (NVAF).
- Willingness to provide informed consent and participate in the study.
- Receiving Elxaban as anticoagulation therapy.
- Ability to use the mobile application.
Key exclusion criteria (19 listed)
- Inability to understand the study or refusal to provide consent.
- Minors under 19 years of age.
- Pregnant or breastfeeding women.
- Conditions requiring chronic anticoagulation therapy other than atrial fibrillation (e.g., mechanical heart valve replacement).
- Life expectancy of less than one year due to severe comorbid conditions.
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 |
|---|---|---|
| AF application enhancing AF education and drug adhrenceThis group will use AF-application. The app will include content related to anticoagulation therapy, such as: medication reminders or intake confirmation for anticoagulants, the importance of anticoagulation therapy in stroke prevention, the role of antiarrhythmic and rate-control medications in symptom management, the necessity of controlling risk factors such as hypertension, diabetes, and hyperlipidemia, and quality of life and cognitive function assessments through questionnaires. | Other | App education group |
| AF application without enhancing AF education and drug adhrenceThis group will use AF-application. However, this application will not contain materials enhancing AF education and adherence. | Other | No-App education group |
Primary outcome
The primary composite outcome
Time frame: every 6 month up to 4 years until the end of study, with a minum follow-up duration of one year.
The primary composite outcome consists of ischemic stroke, intracranial hemorrhage, and myocardial infarction.
18 secondary outcomes
Secondary end points assessed time to stroke (ischemic and hemorrhagic)
Time frame: every 6 month up to 4 years until the end of study
transient ischemic attack (TIA)
Time frame: every 6 month up to 4 years until the end of study
systemic embolism
Time frame: every 6 month up to 4 years until the end of study
major bleeding
Time frame: every 6 month up to 4 years until the end of study
clinically relevant non-major bleeding
Time frame: every 6 month up to 4 years until the end of study
myocardial infarction
Time frame: every 6 month up to 4 years until the end of study
death
Time frame: every 6 month up to 4 years until the end of study
hospitalization events
Time frame: every 6 month up to 4 years until the end of study
medication adherence
Time frame: every 6 month up to 4 years until the end of study
Secondary end points assessed time to stroke (ischemic and hemorrhagic)
Time frame: a minum follow-up duration of one year.
transient ischemic attack (TIA)
Time frame: a minum follow-up duration of one year.
systemic embolism
Time frame: a minum follow-up duration of one year.
major bleeding
Time frame: a minum follow-up duration of one year.
clinically relevant non-major bleeding
Time frame: a minum follow-up duration of one year.
myocardial infarction
Time frame: a minum follow-up duration of one year.
death
Time frame: a minum follow-up duration of one year.
hospitalization events
Time frame: a minum follow-up duration of one year.
medication adherence
Time frame: a minum follow-up duration of one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
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?
A study testing AF application enhancing AF education and drug adhrence and AF application without enhancing AF education and drug adhrence in people with Atrial Fibrillation on Apixaban Treatment, run by Yonsei University at 1 site in South Korea.
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 19 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: opening soon, as of the sponsor's last update on 11 Mar 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary composite outcome (time frame: every 6 month up to 4 years until the end of study, with a minum follow-up duration of one year.). 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 11 Mar 2025.