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Completed

NCT Number: NCT05557123

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI-app

Device

MEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication.

Primary outcomes

  1. Drug adherence

    Time frame: 24 week

    Drug adherence by pill count

  2. Proportion of adequate medication adherence at 24 weeks

    Time frame: 24 weeks

    proportion of patients with ≥95% of continuous medication adherence

Secondary outcomes

  1. 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.)

  2. The occurrence of MACCE and hospitalization

    Time frame: 24 week

    MACCE plus hospitalization

  3. The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)

    Time frame: 24 week

    Stroke, TIA, Pulmonary embolism)

  4. The occurrence of bleeding

    Time frame: 24 week

    bleeding event

  5. Drug adherence

    Time frame: 12 week

    Drug adherence by pill count

  6. Proportion of adequate medication adherence at 12 weeks

    Time frame: 12 week

    proportion of patients with ≥95% of continuous medication adherence

  7. medication adherence by zero-inflated model

    Time frame: 12 week and 24 weeks

    medication adherence by zero-inflated model

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • SAMJIN PHARM

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2022
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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