Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: conventional treatment; Device: MEDI-app

• Registration Number: NCT05557123
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-25
• Study First Posted: 2022-09-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1042

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment	conventional treatment	conventional treatment
MEDI-app	MEDI-app	conventional treatment with MEDI-app feedback

Primary Outcome Measures

Name	Time	Method
Proportion of adequate medication adherence at 24 weeks	24 weeks	proportion of patients with ≥95% of continuous medication adherence
Drug adherence	24 week	Drug adherence by pill count

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of