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

NCT ID: NCT05557123

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1042 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEDI-app

conventional treatment with MEDI-app feedback

Group Type EXPERIMENTAL

MEDI-app

Intervention Type DEVICE

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

conventional treatment

conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MEDI-app

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SAMJIN PHARM

UNKNOWN

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Ju Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Ju Choi, MD, PhD

Role: STUDY_CHAIR

Seoul National Univeristy Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong-Ju Choi, MD, PhD

Role: CONTACT

+82317877007

Minjae Yoon, MD

Role: CONTACT

+821063341917

Facility Contacts

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Dong-Ju Choi, MD, PhD

Role: primary

+82317877007

Minjae Yoon, MD

Role: backup

+82317877074

References

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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.

Reference Type DERIVED
PMID: 37324622 (View on PubMed)

Other Identifiers

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RIVOX-AF

Identifier Type: -

Identifier Source: org_study_id

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