Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)
May 15, 2026 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
637
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seongnam, South Korea, 13620
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MEDI-app
conventional treatment with MEDI-app feedback
|
MEDI-app based feedback algorithm.
The app based feedback algorithm will check and remind the patients of taking medication.
|
|
No Intervention: conventional treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drug adherence
Time Frame: 24 week
|
Drug adherence by pill count
|
24 week
|
|
Proportion of adequate medication adherence at 24 weeks
Time Frame: 24 weeks
|
proportion of patients with ≥95% of continuous medication adherence
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The occurrence of clinical composite end point
Time Frame: 24 week
|
composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.)
|
24 week
|
|
The occurrence of MACCE and hospitalization
Time Frame: 24 week
|
MACCE plus hospitalization
|
24 week
|
|
The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)
Time Frame: 24 week
|
Stroke, TIA, Pulmonary embolism)
|
24 week
|
|
The occurrence of bleeding
Time Frame: 24 week
|
bleeding event
|
24 week
|
|
Drug adherence
Time Frame: 12 week
|
Drug adherence by pill count
|
12 week
|
|
Proportion of adequate medication adherence at 12 weeks
Time Frame: 12 week
|
proportion of patients with ≥95% of continuous medication adherence
|
12 week
|
|
medication adherence by zero-inflated model
Time Frame: 12 week and 24 weeks
|
medication adherence by zero-inflated model
|
12 week and 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Dong-Ju Choi, MD, PhD, Seoul National Univeristy Bundang Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2022
Primary Completion (Actual)
December 16, 2025
Study Completion (Actual)
December 16, 2025
Study Registration Dates
First Submitted
September 20, 2022
First Submitted That Met QC Criteria
September 25, 2022
First Posted (Actual)
September 27, 2022
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIVOX-AF
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.