ISRCTN17309850已完成3 期
on-vitamin K Antagonist Oral Anticoagulants in patients with atrial high rate episodes - an investigator-driven, prospective, randomised, double-blind, multi-centre trial initiated by the European Society of Cardiology and AFNET
Kompetenznetz Vorhofflmmern e.V. (Atrial Fibrillation NETwork - AFNET)0 个研究点目标入组 2,535 人开始时间: 2016年1月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,535
研究概览
简要总结
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28760205 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37622677/ (added 29/08/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 19/03/2020:
- •1. Implanted pacemaker, defibrillator or insertable cardiac monitor with feature of detection of AHRE, implanted at least 2 months prior to randomization
- •2. AHRE detection feature activated adequately according to Suggestions for optimal programming of devices for adequate detection of AHRE
- •3. AHRE (= 170 bpm atrial rate and = 6 min duration) documented by the implanted device via its atrial lead and stored digitally. AHRE episodes detected in the first 2 months after implantation of a new device involving placement or repositioning of electrodes are not counted. 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 electrodes, are eligible.
- •4. Aged 65 years or over
- •5. In addition, at least one of the following cardiovascular conditions leading to a modified CHA2DS2VASc score of 2 or more:
- •a. Age = 75 years
- •b. Heart failure (clinically overt or LVEF < 45%)
- •c. Arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg)
- •d. Diabetes mellitus
- •e. Prior stroke or transient ischemic attack (TIA)
- •f. Vascular disease (previous myocardial infarction, peripheral, carotid/cerebral, or aortic plaques on transesophageal echocardiogram [TEE])
- •6. Provision of signed informed consent
- •Previous participant inclusion criteria as of 27/09/2018:
- •1. Implanted pacemaker or defibrillator with feature of detection of AHRE, implanted at least 2 months prior to randomisation
- •2. AHRE detection feature activated adequately according to Suggestions for optimal programming of devices for adequate detection of AHRE
- •3. AHRE (= 180 bpm atrial rate and = 6 min duration) documented by the implanted device via its atrial lead and stored digitally. AHRE episodes detected in the first 2 months after implantation of a new device involving placement or repositioning of electrodes are not counted. 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 electrodes, are eligible.
- •4. Aged 65 years or over
- •5. In addition, at least one of the following cardiovascular conditions leading to a modified CHA2DS2VASc score of 2 or more:
- •5.1. Age = 75 years;
- •5.2. Heart failure (clinically overt or LVEF < 45%);
- •5.3. Arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihyper-tensive therapy or resting blood pressure > 145/90 mmHg);
- •5.4. Diabetes mellitus;
- •5.5. Prior stroke or transient ischemic attack (TIA);
- •5.6. Vascular disease (previous myocardial infarction, peripheral, carotid/cerebral, or aortic plaques on transesophageal echocardiogram [TEE]).
- •6. Provision of signed informed consent
- •Previous participant inclusion criteria:
- •1. Implanted pacemaker or defibrillator with feature of detection of AHRE, i
排除标准
- •1. Any disease that limits life expectancy to less than 1 year
- •2. Participation in another controlled clinical trial, either within the past two months or still ongoing
- •3. Previous participation in the present trial NOAH
- •4. Drug abuse or clinically manifest alcohol abuse. Exclusion criteria related to a cardiac condition
- •5. Any history of overt AF or atrial flutter
- •6. Indication for oral anticoagulation (e.g. deep venous thrombosis)
- •7. Contraindication for oral anticoagulation in general
- •8. Contraindication for edoxaban as stated in the current SmPC
- •9. Indication for long-term antiplatelet therapy other than acetylsalicylic acid, especially dual antiplatelet therapy (DAPT) with acetylsalicylic acid and one of the following agents: clopidogrel, prasugrel, or ticagrelor. 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
- •10. Acute coronary syndrome, coronary revascularisation (PCI or bypass surgery), or overt stroke within 30 days prior to randomisation
- •11. End stage renal disease (creatinine clearance (CrCl) < 15 ml/min as calculated by the Cockcroft-Gault method)
研究者
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