Anticoagulation using the direct factor Xa inhibitor apixaban during atrial fibrillation catheter ablation and comparison to vitamin K antagonist therapy: A investigator-initiated, prospective, parallel-group, randomised, open, blinded outcome assessment (PROBE) interventional multi-centre trial.

Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]0 个研究点目标入组 674 人开始时间: 2014年6月20日最近更新: 2019年5月27日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 674

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28130378 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29579168 [added 13/05/2019]

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation
•2. Clinical indication to undergo catheter ablation on continuous anticoagulant therapy
•3. Presence of at least one of the CHADS2 stroke risk factors
•3a. Stroke or TIA
•3b. Age =75 years
•3c. Hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure >145/90 mm Hg
•3d. Diabetes mellitus
•3e. Symptomatic heart failure (NYHA =II)
•4. Age =18 years
•5. Provision of signed informed consent

排除标准

•General exclusion criteria
•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 still ongoing
•3. Previous participation in AXAFA
•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) or sterile women can be randomised.
•5. Breastfeeding women
•6. Drug abuse or clinically manifest alcohol abuse
•Added 18/10/2017:
•7. Any stroke within 14 days before randomisation
•8. 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 (Appendix VIII)
•Exclusion criteria related to a cardiac condition
•9. 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.
•10. Any previous ablation or surgical therapy for AF
•11. Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
•12. Clinical need for ?triple therapy? (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
•13. Other contraindications for use of VKA or apixaban
•Exclusion criteria based on laboratory abnormalities
•14. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) <15 ml/min
•Added 18/10/2017: 15. Documented atrial thrombi less than 3 months prior to randomisation

研究者

发起方

Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]

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