Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06903845

APIXABAN App Study

The aim of this clinical trial is to evaluate whether the medication reminder app and video call can improve medication adherence to apixaban in patients with AF and comorbidities.

Patients with AF and comorbid heart disease taking apixaban who meet the inclusion criteria will be randomised 1:1 to a treatment arm using a medication reminder app and bi-weekly video education and a control arm using the medication reminder app alone to compare medication adherence.

Patients in both groups will use the medication app, but only the treatment group will receive additional education and feedback via video call every two weeks to reinforce the use of the medication app and medication reminders with video education.

The study aims to assess the change in adherence between the two groups at week 8.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Health Behavior Heart Diseases Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, 13620, South Korea

Location status: Recruiting

Location contact

Minjae Yoon, MD

CONTACT

[email protected]

82-10-6334-1917

Who can participate

Healthy volunteers accepted: No

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

Participants must meet all of the following criteria:

Adults aged 19 years or older with a diagnosis of atrial fibrillation (AF)

Presence of at least one of the following cardiovascular or metabolic comorbidities:

A. Heart failure

B. Hypertension

C. Coronary artery disease

D. Peripheral arterial disease

E. Diabetes mellitus

F. Stroke

G. Other cardiac diseases requiring treatment

Currently taking or planning to initiate oral anticoagulation therapy with apixaban

Able to use a smartphone with an Android operating system

Voluntarily provided written informed consent to participate in the clinical trial after being adequately informed of its purpose, procedures, and potential risks

  • Exclusion Criteria

Participants will be excluded if any of the following conditions apply:

Creatinine clearance (CCr) < 15 mL/min

Presence of moderate to severe mitral stenosis

History of mitral valve repair or replacement

Clinically significant history of alcohol or substance abuse

Deemed by the investigator to be legally or psychologically unsuitable for participation in the clinical trial

Participation in another clinical trial involving investigational drugs within 4 weeks prior to screening

Declines or is unwilling to provide informed consent for participation in this study

Treatment and study plan

video call

Procedure

Conduct video training every two weeks emphasizing medication adherence.

Medication Reminder App

Device

Medication reminder app will remind patients to take your medication.

Primary outcomes

  1. Medication adherence by pill count

    Time frame: From enrollment to the end of treatment at 8 weeks

    Medication adherence by pill count: both the value itself and the percentage of 100% achieved

Secondary outcomes

  1. Medication adherence by App. Calculation

    Time frame: From enrollment to the end of treatment at 8 weeks

    Medication adherence by App. Calculation

  2. Clinical composite end poin

    Time frame: From enrollment to the end of treatment at 8 weeks

    Clinical composite end point: including composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death

  3. App adherence by log trail

    Time frame: From enrollment to the end of treatment at 8 weeks

    App adherence by log trail

  4. Change in adherence questionnaire scores from baseline to week 8

    Time frame: From enrollment to the end of treatment at 8 weeks

    Change in adherence questionnaire scores from baseline to week 8 Rated on a scale of 1 to 5, with higher scores being better

Study contacts

Contact information is provided by the study sponsor or research team.

Minjae Yoon, MD

CONTACT

[email protected]

82-10-6334-1917

Sponsors and collaborators

Lead sponsor

Dong-Ju Choi

Other

Registry information

Official study title

The Effect of App. for Medication-check and Video-call Guided Education on APIXABAN Adherence in Patients of Atrial Fibrillation With Cardiac Disease: Randomised Control Pilot Study(APIXABAN Study)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Apr 6, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.