NCT05557123已完成不适用
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)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 637
- 试验地点
- 2
- 主要终点
- Drug adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MEDI-app
Experimental
conventional treatment with MEDI-app feedback
干预措施: MEDI-app (Device)
conventional treatment
No Intervention
conventional treatment
结局指标
主要结局
Drug adherence
时间窗: 24 week
Drug adherence by pill count
Proportion of adequate medication adherence at 24 weeks
时间窗: 24 weeks
proportion of patients with ≥95% of continuous medication adherence
次要结局
- The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)(24 week)
- The occurrence of bleeding(24 week)
- Drug adherence(12 week)
- The occurrence of clinical composite end point(24 week)
- The occurrence of MACCE and hospitalization(24 week)
- Proportion of adequate medication adherence at 12 weeks(12 week)
- medication adherence by zero-inflated model(12 week and 24 weeks)
研究者
Dong-Ju Choi
Professor
Seoul National University Bundang Hospital
研究点 (2)
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