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| Name | Class |
|---|---|
| SAMJIN PHARM | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI-app | Experimental | conventional treatment with MEDI-app feedback |
|
| conventional treatment | No Intervention | conventional treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-app | Device | MEDI-app based feedback algorithm. The app based feedback algorithm will check and remind the patients of taking medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of clinical composite end point | composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death.) | 24 week |
| The occurrence of MACCE and hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Ju Choi, MD, PhD | Seoul National Univeristy Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37324622 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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MACCE plus hospitalization
| 24 week |
| The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism) | Stroke, TIA, Pulmonary embolism) | 24 week |
| The occurrence of bleeding | bleeding event | 24 week |
| Drug adherence | Drug adherence by pill count | 12 week |
| Proportion of adequate medication adherence at 12 weeks | proportion of patients with ≥95% of continuous medication adherence | 12 week |
| medication adherence by zero-inflated model | medication adherence by zero-inflated model | 12 week and 24 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |