EUCTR2010-021258-20-IT进行中（未招募）不适用
Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST) - EAST
KOMPETENZNETZ VORHOFFLIMMERN E.V. (AFNET)0 个研究点目标入组 2,810 人开始时间: 2012年9月26日最近更新:
试验速览
- 阶段
- 不适用
- 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
- •The following main criteria must be present for eligibility into the study: Recent onset AF, i.e. AF with a known history of =1 year prior to randomisation; Risk for stroke as evidenced by EITHER a) one of the following: age > 75 years, prior stroke or transient ischemic attack (TIA) OR b) two of the following: hypertension, diabetes mellitus, left ventricular hypertrophy, age > 65 years, female sex, peripheral artery disease, kidney disease (MDRD stage III or IV), stable heart failure (NYHA II or LVEF <50%), severe coronary artery disease (previous myocardial infarction, CABG or PCI)
- •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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