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

Atrial Fibrillation Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557123
• Other study ID #: RIVOX-AF
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Seoul National University Bundang Hospital
• Contact: Dong-Ju Choi, MD, PhD
• Phone: +82317877007
• Email: djchoi[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1054
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients with atrial fibrillation with aged 19 years or older

• one or more of the following : heart failure, MI (3 month after onset), angina (3 month after PCI), hypertension or diabetes mellitus

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• MEDI-app
MEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication.
• conventional treatment
conventional treatment with rivoxaban

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	SAMJIN PHARM

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug adherence	Drug adherence by pill count	24 week
Secondary	The occurrence of clinical composite end point	composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.)	24 week
Secondary	The occurrence of MACCE and hospitalization	MACCE plus hospitalization	24 week
Secondary	The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)	Stroke, TIA, Pulmonary embolism)	24 week
Secondary	The occurrence of bleeding	bleeding event	24 week
Secondary	Drug adherence	Drug adherence by pill count	12 week