Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, mobile app
Brief 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.
Interventions
DEVICEMEDI-app
MEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication.
Sponsors
Seoul National University Bundang Hospital
SAMJIN PHARM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug adherence | 24 week | Drug adherence by pill count |
| Proportion of adequate medication adherence at 24 weeks | 24 weeks | proportion of patients with ≥95% of continuous medication adherence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of clinical composite end point | 24 week | composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.) |
| The occurrence of MACCE and hospitalization | 24 week | MACCE plus hospitalization |
| The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism) | 24 week | Stroke, TIA, Pulmonary embolism) |
| The occurrence of bleeding | 24 week | bleeding event |
| Drug adherence | 12 week | Drug adherence by pill count |
| Proportion of adequate medication adherence at 12 weeks | 12 week | proportion of patients with ≥95% of continuous medication adherence |
| medication adherence by zero-inflated model | 12 week and 24 weeks | medication adherence by zero-inflated model |
Countries
South Korea
Contacts
STUDY_CHAIRDong-Ju Choi, MD, PhD
Seoul National Univeristy Bundang Hospital
Outcome results
None listed