Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 10
- 主要终点
- A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.
研究概览
简要总结
In this multi centre pilot study we will perform TEE in patients with AF who are eligible for VKA treatment. TTE will be used as pre-screening: if TTE shows left atrial abnormalities or aortic plaque, patients will be excluded from randomisation. TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis. Three hundred patients who do not have these features on TTE will be randomly assigned to treatment with aspirin or VKA. Follow-up will be 1 year.
详细描述
BACKGROUND Atrial fibrillation (AF) is an independent risk factor for stroke. Therapy with vitamin K antagonists (VKA) and aspirin reduces the risk of thromboembolism (TE) dramatically. Risk stratification is nowadays based on clinical characteristics. However, many high risk AF patients may actually be at low risk, identified by trans-oesophageal echocardiography (TEE).
HYPOTHESIS A comprehensive strategy of TEE based aspirin treatment in AF patients eligible for VKA therapy is safe and feasible.
OBJECTIVES
- To show that TEE based aspirin treatment is safe when compared with VKA therapy.
- To test the feasibility of TEE as a tool to detect all four echocardiographic features of high stroke risk.
METHODS In this multi centre pilot study we will perform TEE in patients with AF who are eligible for VKA treatment. TTE will be used as pre-screening: if TTE shows left atrial abnormalities or aortic plaque, patients will be excluded from randomisation. TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis. Three hundred patients who do not have these features on TTE will be randomly assigned to treatment with aspirin or VKA. Follow-up will be 1 year.
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
- •Documented atrial fibrillation or atrial flutter, paroxysmal or permanent
- •Conventional indication for VKA treatment
- •Signed informed consent
排除标准
- •Planned electro cardioversion
- •Very high risk of TE (previous ischemic stroke or systemic TE, symptoms of heart failure or left ventricular dysfunction, mitral valve stenosis, hypertrophic cardiomyopathy)
- •Indication for VKA treatment other than atrial fibrillation (e.g. mechanic valve prosthesis)
- •Atrial fibrillation secondary to reversible diseases (e.g. thyrotoxicosis)
- •Contraindication for treatment with VKA, aspirin, or clopidogrel
结局指标
主要结局
A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.
时间窗: at least 1 year
次要结局
- Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.(1 year)
研究者
NHT Dinh
Drs.
The Interuniversity Cardiology Institute of the Netherlands