Atrial FibrillationNCT05557123
Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)
A study testing MEDI-app in people with Atrial Fibrillation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
RIVOX-AF study is a prospective, multicenter, randomized controlled study in which patients with AF are allocated to medication-app group or conventional treatment group. The App based feed-back algorithm will provide the patients with check taking drug or reminding of taking drug. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- MEDI-app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2022to 16 Dec 2025
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AF aged 19 years or older with one or more comorbidities including heart failure, myocardial infarction, stable angina, hypertension or diabetes mellitus (Patients can be enrolled 3 months after myocardial infarction or percutaneous coronary intervention).
- patients who already took or plan to take rivoxban
- patients who able to use smart phone
Who cannot join
- creatinine clearance <15ml/min
- moderate or severe mitral stenosis
- mitral valve operation history
- current alcohol abuse or alcohol abus history
- Not eligible for study due to legal or psychiatric problem
- enrolled other clinical study within 4 weeks
- declined to enroll the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: The ReInforcement of Adherence Via Self-monitoring App Orchestrating Biosignals and Medication of RivoXaban in Patients With Atrial Fibrillation and Co-morbidities: Randomised Control Study(RIVOX-AF Study)
RIVOX-AF study is a prospective, multicenter, randomized controlled study in which patients with AF are allocated to medication-app group or conventional treatment group. The App based feed-back algorithm will provide the patients with check taking drug or reminding of taking drug.
- Conditions
- Atrial Fibrillation
- Being tested
- MEDI-app
- Keywords
- atrial fibrillation, mobile app
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-appDevice
MEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication.
| Study group | Role | What they receive |
|---|---|---|
| MEDI-app | Experimental | conventional treatment with MEDI-app feedback Receives: Device: MEDI-app |
| conventional treatment | No intervention | conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug adherence
Drug adherence by pill count
Measured: 24 week
Proportion of adequate medication adherence at 24 weeks
proportion of patients with ≥95% of continuous medication adherence
Measured: 24 weeks
Secondary outcomes (7)
The occurrence of clinical composite end point
composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.)
Measured: 24 week
The occurrence of MACCE and hospitalization
MACCE plus hospitalization
Measured: 24 week
The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)
Stroke, TIA, Pulmonary embolism)
Measured: 24 week
The occurrence of bleeding
bleeding event
Measured: 24 week
Drug adherence
Drug adherence by pill count
Measured: 12 week
Proportion of adequate medication adherence at 12 weeks
proportion of patients with ≥95% of continuous medication adherence
Measured: 12 week
medication adherence by zero-inflated model
medication adherence by zero-inflated model
Measured: 12 week and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start10 Mar 2022
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SAMJIN PHARM
- Responsible party
- Principal investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
- Investigators
- Dong-Ju Choi, MD, PhD, Study chair, Seoul National Univeristy Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557123
- Sponsor's protocol ID
- RIVOX-AF
- Status last verified
- May 2026
- First submitted
- 20 Sep 2022
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon M, Park JJ, Hur T, Hua CH, Shim CY, Yoo BS, Cho HJ, Lee S, Kim HM, Kim JH, Lee S, Choi DJ. The ReInforcement of adherence via self-monitoring app orchestrating biosignals and medication of RivaroXaban in patients with atrial fibrillation and co-morbidities: a study protocol for a randomized controlled trial (RIVOX-AF). Front Cardiovasc Med. 2023 May 24;10:1130216. doi: 10.3389/fcvm.2023.1130216. eCollection 2023.
PubMed 37324622
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ReInforcement of Adherence Via Self-monitoring App Orchestrating Biosignals and Medication of RivoXaban in Patients With Atrial Fibrillation and Co-morbidities: Randomised Control Study(RIVOX-AF Study)
- ClinicalTrials.gov ID
- NCT05557123
- Acronym / sponsor ID
- RIVOX-AF
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- SAMJIN PHARM
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 27 Sep 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.
RIVOX-AF study is a prospective, multicenter, randomized controlled study in which patients with AF are allocated to medication-app group or conventional treatment group. The App based feed-back algorithm will provide the patients with check taking drug or reminding of taking drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI-app | Experimental | Device: MEDI-appconventional treatment with MEDI-app feedback |
| conventional treatment | No intervention | –conventional treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with AF aged 19 years or older with one or more comorbidities including heart failure, myocardial infarction, stable angina, hypertension or diabetes mellitus (Patients can be enrolled 3 months after myocardial infarction or percutaneous coronary intervention).
- patients who already took or plan to take rivoxban
- patients who able to use smart phone
Key exclusion criteria (7 listed)
- creatinine clearance <15ml/min
- moderate or severe mitral stenosis
- mitral valve operation history
- current alcohol abuse or alcohol abus history
- Not eligible for study due to legal or psychiatric problem
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 |
|---|---|---|
| MEDI-appMEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication. | Device | MEDI-app |
Primary outcome
Drug adherence
Time frame: 24 week
Drug adherence by pill count
Proportion of adequate medication adherence at 24 weeks
Time frame: 24 weeks
proportion of patients with ≥95% of continuous medication adherence
7 secondary outcomes
The occurrence of clinical composite end point
Time frame: 24 week
The occurrence of MACCE and hospitalization
Time frame: 24 week
The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)
Time frame: 24 week
The occurrence of bleeding
Time frame: 24 week
Drug adherence
Time frame: 12 week
Proportion of adequate medication adherence at 12 weeks
Time frame: 12 week
medication adherence by zero-inflated model
Time frame: 12 week and 24 weeks
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 19 May 2026.
- Derived from this study: PubMed 37324622Yoon M, Park JJ, Hur T, Hua CH, Shim CY, Yoo BS, Cho HJ, Lee S, Kim HM, Kim JH, Lee S, Choi DJ. The ReInforcement of adherence via self-monitoring app orchestrating biosignals and medication of RivaroXaban in patients with atrial fibrillation and co-morbidities: a study protocol for a randomized controlled trial (RIVOX-AF). Front Cardiovasc Med. 2023 May 24;10:1130216. doi: 10.3389/fcvm.2023.1130216. eCollection 2023.
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Atrial Fibrillation (AF)
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.
Dong-Ju Choi, MD, PhD study chair
Seoul National Univeristy Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDI-app in people with Atrial Fibrillation, run by Seoul National University Bundang Hospital 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 3 inclusion and 7 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 19 May 2026. 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?
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?
Drug adherence (time frame: 24 week). 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?
On the ClinicalTrials.gov record for NCT05557123, which also lists 1 linked publication.
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 19 May 2026.