NCT03753490进行中（未招募）不适用
ABC-Risk Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - a Multicenter, Registry-based, Randomized Controlled Parallel-group Open-label Study
Uppsala University1 个研究点 分布在 1 个国家目标入组 3,933 人开始时间: 2018年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,933
- 试验地点
- 1
- 主要终点
- Composite of Stroke or Death
研究概览
简要总结
The primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or standard care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment
- •Signed informed consent
排除标准
- •Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
- •Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
- •Currently on treatment with a non-vitamin K antagonist oral anticoagulant (NOAC) and not eligible for change of NOAC drug e.g. drug-drug interactions
- •Concomitant dual antiplatelet treatment
- •Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
- •Participation in anti-thrombotic pharmaceutical trial
- •Planned for AF ablation or AF surgery
- •Haemoglobin <90 g/L
- •Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol
结局指标
主要结局
Composite of Stroke or Death
时间窗: From the date of enrolment through study completion, minimum follow-up 2 years.
次要结局
- Stroke(From the date of enrolment through study completion, minimum follow-up 2 years.)
- Death(From the date of enrolment through study completion, minimum follow-up 2 years.)
- Major Bleeding(From the date of enrolment through study completion, minimum follow-up 2 years.)
- Myocardial Infarction(From the date of enrolment through study completion, minimum follow-up 2 years.)
- Heart Failure(From the date of enrolment through study completion, minimum follow-up 2 years.)
- Health Economics(From the date of enrolment through study completion, minimum follow-up 2 years.)
研究者
研究点 (1)
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