EUCTR2015-003997-33-DK进行中（未招募）1 期
on-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes
Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]0 个研究点目标入组 2,538 人开始时间: 2020年11月25日最近更新:
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
- 2,538
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
- •-Pacemaker, defibrillator or insertable cardiac monitor implanted for any reason with feature of detection of AHRE, implanted at least 2 months prior to randomisation.
- •-AHRE detection feature activated for adequate detection of AHRE”
- •-AHRE (= 170 bpm atrial rate and = 6 min duration) documented by the implanted device.
- •Any AHRE episode recorded is potentially eligible, but AHRE episodes detected in the first 2 months after implantation of a new device involving placement or repositioning of atrial electrodes are not eligible. AHRE episodes recorded in the first two months after a simple box change” operation, i.e. exchange of a pacemaker or defibrillator device without exchange or repositioning of atrial electrodes, are eligible.
- •-Age = 65 years
- •-In addition, at least one of the following cardiovascular conditions leading to a modified CHA2DS2VASc score of 2 or more: Age = 75 years, heart failure (clinically overt or LVEF < 45%), arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg), diabetes mellitus, prior stroke or transient ischemic attack (TIA), vascular disease (previous myocardial infarction, peripheral,
- •carotid/cerebral, or aortic plaques on transesophageal echocardiogram
- •-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) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2538
排除标准
- •-Any disease that limits life expectancy to less than 1 year.
- •-Participation in another controlled clinical trial, either within the past two months or still ongoing.
- •-Previous participation in the present trial NOAH - AFNET 6.
- •-Drug abuse or clinically manifest alcohol abuse.
- •-Any history of overt AF or atrial flutter.
- •-Indication for oral anticoagulation (e.g. deep venous thrombosis).
- •-Contraindication for oral anticoagulation in general.
- •-Contraindication for edoxaban as stated in the current SmPC.
- •-Indication for long-term antiplatelet therapy other than acetylsalicylic acid or a need for treatment with any antiplatelet agent in addition to edoxaban, especially dual antiplatelet therapy (DAPT). Patients with a transient requirement for DAPT (e.g. after receiving a stent) will be eligible when the need for DAPT is no longer present.
- •-Acute coronary syndrome, coronary revascularisation (PCI or bypass surgery), or overt stroke within 30 days prior to randomisation.
- •-End stage renal disease (creatinine clearance (CrCl) < 15 ml/min as calculated by the Cockcroft-Gault method)
- •Legal exclusion criterion (applicable in countries where legally required)
- •-All persons exempt from participation in a clinical trial by law.
研究者
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