An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,374
- 试验地点
- 5
- 主要终点
- Change in proportion of patients taking oral anticoagulants
研究概览
简要总结
To determine whether a comprehensive evaluation and customized multilevel educational interventions will increase the rate of use of oral anticoagulants and the adherence and persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be differences in the use of oral anticoagulants and the persistence in patients between the control and interventional group. There will be a greater change in the use of oral anticoagulants over one year in the cohort in the intervention sites than the control sites. This will be due to two factors: greater initiation of oral anticoagulants among patients not treated at baseline and greater persistence of treatment for those on treatment at baseline
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 with paroxysmal, persistent or permanent atrial fibrillation who have a 12-lead ECG showing atrial fibrillation and/or more than one rhythm strip showing atrial fibrillation at least 2 weeks apart, not due to a reversible cause (like post-CABG))
- •At least one of the traditional CHADS2 risk factors or at least two CHA2DS2 VASc risk factors
排除标准
- •Mechanical prosthetic valve
- •Clinically unstable at the time of enrollment (ie, with ongoing shock)
- •Terminal illness and/or comfort care
- •Unable to provide consent (e.g. severe cognitive impairment)
- •Patients unable to have one year of follow-up for any reason
- •Clear and absolute contraindication to oral anticoagulation (for example, active bleeding or recent life-threatening bleeding such as ICH)
研究组 & 干预措施
Intervention
educational intervention arm
干预措施: Educational Intervention (Other)
control
Standard of care
结局指标
主要结局
Change in proportion of patients taking oral anticoagulants
时间窗: 1 year
Change in proportion of patients taking oral anticoagulants from baseline to one year
次要结局
- Death, total(1 year)
- Major and non-major clinically relevant bleeding(1 year)
- Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation(1 year)
- Stroke, hemorrhagic and non-hemorrhagic(1 year)
- Change in proportion of patients able to continue anticoagulation(1 year)