Early treatment of atrial fibrillation for stroke prevention trial

Phase 4

Completed

Conditions: Recent onset atrial fibrillation/stroke risk
Circulatory System
Atrial fibrillation

Registration Number: ISRCTN04708680

Lead Sponsor: German Atrial Fibrillation Network (Germany)

Brief Summary: 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2789

Inclusion Criteria

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

Exclusion Criteria

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)