EUCTR2014-002442-45-DK进行中（未招募）1 期
Anticoagulation using the direct factor Xa inhibitor apixaban during Atrial Fibrillation catheter Ablation: Comparison to vitamin K antagonist therapy. - AXAFA
Kompetenznetz Vorhofflimmern e.V. [Atrial Fibrillation NETwork (AFNET)]0 个研究点目标入组 650 人开始时间: 2014年11月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
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
- •I1. Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation
- •I2. Clinical indication to undergo catheter ablation on continuous anticoagulant therapy
- •I3. Presence of at least one of the CHADS2 stroke risk factors
- •- Stroke or TIA
- •- age = 75 years,
- •- hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mm Hg,
- •- diabetes mellitus,
- •- symptomatic heart failure (NYHA = II).
- •I4. Age = 18 years
- •I5. Provision of signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
排除标准
- •General exclusion criteria
- •E1. Any disease that limits life expectancy to less than 1 year
- •E2. Participation in another clinical trial, either within the past two months or still ongoing
- •E3. Previous participation in AXAFA
- •E4. 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) or sterile women can be randomised.
- •E5. Breastfeeding women
- •E6. Drug abuse or clinically manifest alcohol abuse
- •E7. Any stroke within 14 days before randomisation
- •E8. Coadministration with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P glycoprotein (P-gp) or strong dual inducers of CYP3A4 and P-gp
- •Exclusion criteria related to a cardiac condition
- •E9. Valvular AF (as defined by the focussed update of the ESC guidelines on AF, i.e. severe mitral valve stenosis, mechanical heart valve). Furthermore, patients who underwent mitral valve repair are not eligible for AXAFA.
- •E10. Any previous ablation or surgical therapy for AF
- •E11. Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
- •E12. Clinical need for triple therapy” (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
- •E13. Other contraindications for use of VKA or apixaban
- •Exclusion criteria based on laboratory abnormalities
- •E14. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) < 15 ml/min
研究者
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