An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial to Determine the Optimal Anticoagulation Therapy for Patients Untergoing Catheter Ablation of Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 676
- 试验地点
- 10
- 主要终点
- death and serious cardiovascular events
研究概览
简要总结
Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications.
The AXAFA trial will compare peri-ablational treatment with apixaban to peri-ablational treatment wit VKA in a randomized trial of patients undergoing catheter ablation of atrial fibrillation (AF).
详细描述
AXAFA is an open-label trial designed to evaluate the safety and efficacy of two types of anticoagulant therapy, VKA therapy and therapy with the direct factor Xa inhibitor apixaban, in patients undergoing scheduled catheter ablation for AF. All patients will undergo the ablation procedure after pre-treatment with an anticoagulant (either apixaban in the "Xa group" or a vitamin K antagonist in the "VKA group").
Patients can undergo catheter ablation within the trial after at least 30 days of continuous effective anticoagulation. Ablation can be performed earlier when or timely after exclusion of atrial thrombi have been excluded by a clinically indicated by transthoracic echocardioggram (TEE). After TEE continuous effective anticoagulation must be ensured until the end of the trial.
In the MRI-substudy will be explored wether novel oral anticoagulants (NOAC) have the potential to reduce clinically silent brain lesions after catheter ablation of AF.
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
- •Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation
- •Clinical indication to undergo catheter ablation on continuous anticoagulant therapy
- •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).
- •Age ≥ 18 years
- •Provision of signed informed consent
排除标准
- •General exclusion criteria
- •Any disease that limits life expectancy to less than 1 year
- •Participation in another clinical trial, either within the past two months or still ongoing
- •Previous participation in AXAFA
- •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.
- •Breastfeeding women
- •Drug abuse or clinically manifest alcohol abuse
- •Any stroke within 14 days before randomisation
- •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
- •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.
- •Any previous ablation or surgical therapy for AF
- •Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
- •Clinical need for "triple therapy" (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
- •Other contraindications for use of VKA or apixaban
- •Documented atrial thrombi less than 3 months prior to randomisation.
- •Exclusion criteria based on laboratory abnormalities
- •Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) < 15 ml/min
研究组 & 干预措施
Apixaban
Xa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)
干预措施: Apixaban (Drug)
Vitamin K antagonist
VKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine
干预措施: Vitamin K antagonist (Drug)
结局指标
主要结局
death and serious cardiovascular events
时间窗: appr. 4 months
A composite of all-cause death, stroke (ischemic stroke, subarachnoid haemorrhage and haemorrhagic stroke), and major bleeding events, def.as BARC 2 or higher
次要结局
- any bleeding event(appr. 4 months)
- major bleeding events acc. to the ISTH and TIMI definitions(appr. 4 months)
- strokes, other systemic embolic events and all-cause death(appr. 4 month)
- hospitalizations for cardiovascular reasons(appr. 4 months)
- Treatment duration prior to ablation and total time on oral anticoagulation(appr. 4 months)
- patients with clinically indicated TEE(appr. 4 months)
- ACT during ablation(during ablation)
- time from randomisation to ablation(appr. 4 months)
- nights spent in hospital after ablation(appr. 4 months)
- health-care related cost calculation(appr. 4 months)
- recurrent Atrial Fibrillation (AF)(appr. 4 months)
- rhythm status at the end of follow-up(end of follow-up)
- vascular access complications leading to prolongation of in-hospital stay or specific therapy(appr. 4 months)
- Quality-of-life changes(baseline to 3 month follow-up)
- cognitive function change(baseline to 3 month follow-up)
- clinically "silent" MRI-detected brain lesions(within 48 hours after ablation procedures)
- Impact of ablation-associated clinically overt strokes or MRI-detected bus clincally "silent" acute brain lesions on cognitive function after ablation(appr. 4 months)