EUCTR2010-021258-20-NL进行中（未招募）1 期
Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST) - EAST
Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.)0 个研究点目标入组 2,810 人开始时间: 2011年8月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,810
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Recent-onset AF (= 1 year prior to enrolment)
- •2. At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 s.
- •one of the following:
- •* age > 75 years or
- •* prior stroke or transient ischemic attack
- •two of the following:
- •* age > 65 years,
- •* female sex,
- •* arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg),
- •* diabetes mellitus (treated by drugs or insulin) or impaired glucose tolerance
- •* severe coronary artery disease (previous myocardial infarction, CABG or PCI)
- •* stable heart failure ( NYHA II or LVEF <50%),
- •* left ventricular hypertrophy on echocardiography (more than 15 mm wall thickness),
- •* chronic kidney disease (MDRD stage III or IV),
- •* peripheral artery disease.
- •4. Provision of signed informed consent.
- •5. Age = 18 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 810
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •1. Any disease that limits life expectancy to less than 1 year.
- •2. Participation in another clinical trial, either within the past two months or ongoing
- •3. Previous participation in the EAST trial.
- •4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized.
- •5. Breastfeeding women.
- •6. Drug abuse.
- •7. Prior AF ablation or surgical therapy of AF.
- •8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone.
- •9. Patients not suitable for rhythm control of AF.
- •10. Severe mitral valve stenosis.
- •11. Prosthetic mitral valve.
- •12. Clinically relevant hepatic dysfunction requiring specific therapy.
- •13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
- •14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis).
研究者
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