An investigator-driven, prospective, parallel-group, randomised, open, blinded outcome assessment (PROBE-design), multicentre trial for the prevention of stroke in high-risk subjects with atrial fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,789
研究概览
简要总结
2011 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/21784740 protocol 2013 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/24016492 rationale and design 2015 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/25646394 article 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32865375/ results (added 02/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34328366/ Subanalysis of patients with heart failure (added 02/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34447995/ Subanalysis in asymptomatic patients (added 31/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34473249/ Analysis of treatment patterns (added 03/09/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35863844/ Association between pattern of atrial fibrillation and outcomes (added 22/07/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35968706/ (added 16/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36036648/ Early rhythm control (added 30/08/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36517170/ subgroup analysis for early rhythm-control therapy (added 16/12/2022) 2023 Results article in https://doi.org/10.1093/cvr/cvad027 Association of genetic risk and outcomes in patients with atrial fibrillation: interactions with early rhythm control in the EAST-AFNET4 trial (added 02/06/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38702961/ Safety and efficacy of long-term sodium channel blocker therapy for early rhythm control (added 07/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Recent-onset AF (less than or equal to 1 year prior to enrolment)
- •2. At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 seconds
- •3. One of the following:
- •3.1. Aged greater than 75 years, or
- •3.2. Prior stroke or transient ischaemic attack
- •OR two of the following:
- •3.3. Aged greater than 65 years
- •3.3. Female sex
- •3.4. Arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure greater than 145/90 mmHg)
- •3.5. Diabetes mellitus
- •3.6. Severe coronary artery disease (previous myocardial infarction, coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI])
- •3.7. Stable heart failure (New York Heart Association [NYHA] II or left ventricular ejection fraction [LVEF] less than 50%)
- •3.8. Left ventricular hypertrophy on echocardiography (more than 15 mm wall thickness)
- •3.9. Chronic kidney disease (Modified Diet in Renal Disease [MDRD] stage III or IV)
- •3.10. Peripheral artery disease
- •4. Provision of signed informed consent
- •5. Age greater than or equal to 18 years
排除标准
- •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 ongoing
- •3. Previous participation in the EAST trial
- •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 (IUD)] or sterile women can be randomised
- •5. Breastfeeding women
- •6. Drug abuse
- •7. Prior AF ablation or surgical therapy of AF
- •8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone
- •9. Patients not suitable for rhythm control of AF
- •10. Severe mitral valve stenosis
- •11. Prosthetic mitral valve
- •12. Clinically relevant hepatic dysfunction requiring specific therapy
- •13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
- •14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis)