Back to resultsMobile App for Improving Adherence of Rivoxaban (RIVOX-AF)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MEDI-app
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Male and female patients with atrial fibrillation wgi 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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MEDI-app
conventional treatment
Arm Description
conventional treatment with MEDI-app feedback
conventional treatment
Outcomes
Primary Outcome Measures
Drug adherence
Drug adherence by pill count
Secondary Outcome Measures
The occurrence of clinical composite end point
composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.)
The occurrence of MACCE and hospitalization
MACCE plus hospitalization
The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)
Stroke, TIA, Pulmonary embolism)
The occurrence of bleeding
bleeding event
Drug adherence
Drug adherence by pill count
Full Information
NCT ID
NCT05557123
First Posted
September 20, 2022
Last Updated
June 29, 2023
Sponsor
Seoul National University Bundang Hospital
Collaborators
SAMJIN PHARM
1. Study Identification
Unique Protocol Identification Number
NCT05557123
Brief Title
Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
SAMJIN PHARM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1054 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MEDI-app
Arm Type
Experimental
Arm Description
conventional treatment with MEDI-app feedback
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
conventional treatment
Intervention Type
Device
Intervention Name(s)
MEDI-app
Intervention Description
MEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication.
Intervention Type
Device
Intervention Name(s)
conventional treatment
Intervention Description
conventional treatment with rivoxaban
Primary Outcome Measure Information:
Title
Drug adherence
Description
Drug adherence by pill count
Time Frame
24 week
Secondary Outcome Measure Information:
Title
The occurrence of clinical composite end point
Description
composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.)
Time Frame
24 week
Title
The occurrence of MACCE and hospitalization
Description
MACCE plus hospitalization
Time Frame
24 week
Title
The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)
Description
Stroke, TIA, Pulmonary embolism)
Time Frame
24 week
Title
The occurrence of bleeding
Description
bleeding event
Time Frame
24 week
Title
Drug adherence
Description
Drug adherence by pill count
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Ju Choi, MD, PhD
Phone
+82317877007
Email
djchoi@snubh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Minjae Yoon, MD
Phone
+821063341917
Email
minjae1677@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD, PhD
Organizational Affiliation
Seoul National Univeristy Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD, PhD
Phone
+82317877007
Email
djchoi@snubh.org
First Name & Middle Initial & Last Name & Degree
Minjae Yoon, MD
Phone
+82317877074
Email
minjae1677@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)
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