EUCTR2015-005503-84-DE进行中（未招募）1 期
A Safety Study Assessing Oral Anticoagulation with Apixaban versus Vitamin-K Antagonists in Patients with Atrial Fibrillation and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment. - AXADIA
Kompetenznetz Vorhofflimmern e.V.0 个研究点目标入组 108 人开始时间: 2016年11月21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
- 108
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
- •End-stage kidney disease (ESKD) with chronic hemodialysis treatment 3 times per week (with at least 3,5 hours per dialysis)
- •Chronic (i.e. repeated) paroxysmal, persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL) documented by standard or Holter ECG on at least 2 separate days before (or apart from) hemodialysis procedures
- •Increased risk of stroke or systemic embolism identified by a CHA2DS2-VASc score of 2 or more as an indication for oral anticoagulation
- •Patients with ischemic stroke that meet the above criteria, can be included after more than 3 months if not severely handicapped (modified Rankin scale 0 or 1 of 6, i.e. no symptoms or no significant disability and able to carry out all usual activities, despite some symptoms (Farrell, Godwin, Richards, and Warlow (1991))
- •Males and females, aged 18 or older
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 79
排除标准
- •AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)
- •Patients with a new onset of hemodialysis within the last 3 months
- •Clinically significant (moderate or severe) aortic and mitral stenosis
- •Conditions other than AF that require chronic anticoagulation (e.g., a prosthetic mechanical heart valve).
- •Active infective endocarditis
- •Active COVID-19 infection or symptoms suggeting COVID-19 infection
- •Any planned interventional or surgical AF or AFL ablation procedure
- •Any active bleeding
- •A serious bleeding event in the previous 6 months before screening
- •Inadequately controlled (HbA1c levels >8.5%) or untreated diabetes
- •History of malignant neoplasms at high risk of current bleeding (see summary of product characteristics (SmPC) of study drugs)
- •Known indication for treatment with NSAIDs (see SmPC of study drugs) - acetylsalicylic acid (ASA) up to 100 mg per day is allowed
- •Impaired liver function e.g., caused by active infection with HIV, HBV or HCV, hepatitis or other liver damage (No limits for ALT and AST values are defined in this study protocol, although mentioned in the SmPC because they are frequently elevated in dialysis patients. In case of clinically relevant increase of ALT or AST level, patient’s eligibility is to be decided by the responsible investigator)
- •Any type of stroke within 3 months prior to baseline
- •Other indication for anticoagulation than AF or AFL
- •Existing Antiphospholipid Syndrome
- •Valvular heart disease requiring surgery
- •A high risk of bleeding (e.g., active peptic ulcer disease, a platelet count of <100,000 per cubic millimeter or hemoglobin level of <8 g per deciliter)
- •Documented hemorrhagic tendencies or blood dyscrasias
- •Current alcohol or drug abuse
- •Life expectancy of less than 1 year
- •Indication for dual platelet inhibition at baseline (ASA = 100 mg/day is allowed, clopidrogel is excluded at any dose).
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