NCT05557123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
637

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

September 20, 2022

Last Update Submit

May 15, 2026

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationmobile app

Outcome Measures

Primary Outcomes (2)

  • Drug adherence

    Drug adherence by pill count

    24 week

  • Proportion of adequate medication adherence at 24 weeks

    proportion of patients with ≥95% of continuous medication adherence

    24 weeks

Secondary Outcomes (7)

  • The occurrence of clinical composite end point

    24 week

  • The occurrence of MACCE and hospitalization

    24 week

  • The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)

    24 week

  • The occurrence of bleeding

    24 week

  • Drug adherence

    12 week

  • +2 more secondary outcomes

Study Arms (2)

MEDI-app

EXPERIMENTAL

conventional treatment with MEDI-app feedback

Device: MEDI-app

conventional treatment

NO INTERVENTION

conventional treatment

Interventions

MEDI-appDEVICE

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

MEDI-app

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Related Publications (1)

  • Yoon M, Park JJ, Hur T, Hua CH, Shim CY, Yoo BS, Cho HJ, Lee S, Kim HM, Kim JH, Lee S, Choi DJ. The ReInforcement of adherence via self-monitoring app orchestrating biosignals and medication of RivaroXaban in patients with atrial fibrillation and co-morbidities: a study protocol for a randomized controlled trial (RIVOX-AF). Front Cardiovasc Med. 2023 May 24;10:1130216. doi: 10.3389/fcvm.2023.1130216. eCollection 2023.

    PMID: 37324622DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dong-Ju Choi, MD, PhD

    Seoul National Univeristy Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 27, 2022

Study Start

March 10, 2022

Primary Completion

December 16, 2025

Study Completion

December 16, 2025

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations

KR(1)