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| [ ...Back to search results ] | [ Print-friendly version ] |
| Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST) |
| ISRCTN | ISRCTN04708680 |
| ClinicalTrials.gov identifier | NCT01288352 |
| Public title | Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST) |
| Scientific title | 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 |
| Acronym | EAST |
| Serial number at source | 2010-021258-20 |
| Study hypothesis |
EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on anti-arrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care.
Patients will be randomised to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate anti-arrhythmic drug therapy at an early timepoint. The initial therapy will be selected by the local investigator. Upon AF recurrence, both modalities will be combined. Usual care will be conducted following the 2010 ESC guidelines for AF treatment. Early rhythm control therapy will be guided by ECG monitoring. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethikkommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster approved on the 9th February 2011 (ref: 2010-274-f-A) |
| Study design | Phase IV randomised open prospective two-armed parallel-group multicentre trial |
| Countries of recruitment | Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom |
| Disease/condition/study domain | Recent onset atrial fibrillation/stroke risk |
| Participants - 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 (treated by drugs or insulin) or impaired glucose tolerance 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 |
| Participants - 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, glomerular filtration rate [GFR] less than 10 ml/min) |
| Anticipated start date | 01/04/2011 |
| Anticipated end date | 01/03/2017 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 2810 (first patient in on 28/07/2011) |
| Interventions |
Usual care group:
Usual care closely follows the suggestions laid out in the 2010 ESC guidelines for AF. In addition to anti-thrombotic therapy and therapy of underlying heart disease, usual care usually consists of an initial attempt to control symptoms by rate control therapy (Metoprolol, Bisoprolol, Digoxin, Digitoxin, Verapamil). Rhythm control interventions are only indicated when symptoms can not be controlled by optimal rate control therapy in the usual care group. Early therapy group: Patients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF. Early-onset rhythm control therapy can consist of: 1. Optimal antiarrhythmic drug therapy (Dronedarone, Amiodarone, Flecainide, Propafenone), 2. Catheter ablation with the aim of pulmonary vein isolation (PVI), 3. Anti-arrhythmic drug therapy and catheter ablation may be supplemented by early cardioversion in patients with persistent AF. All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences. Duration: EAST is an event-driven trial, i.e. the trial will be terminated after 685 evaluable primary outcomes have occured. A duration of the entire trial of around 6 years is expected. All patients will be followed-up until the end of the trial with a minimum follow-up period of two years. |
| Primary outcome measure(s) |
1. A composite of cardiovascular death, stroke/transient ischaemic attack (TIA), and hospitalisation due to worsening of heart failure or due to acute coronary syndrome
2. Nights spent in hospital per year |
| Secondary outcome measure(s) |
1. Cardiovascular death
2. Stroke/transient ischaemic attack 3. Worsening of heart failure assessed by hospitalisations 4. Acute coronary syndrome assessed by hospitalisations 5. Time to recurrent atrial fibrillation 6. Cardiovascular hospitalisations 7. All-cause hospitalisations 8. Left ventricular function assessed by transthoracic echocardiography at month 24 (+/- 2 months) after randomisation 9. Quality of life changes assessed by EQ-5D and 12-item short form health survey (SF-12) at month 24 (+/- 2 months) after randomisation 10. Cognitive function assessed by MoCA at month 24 (+/- 2 months) after randomisation |
| Sources of funding | German Atrial Fibrillation Network (Germany) |
| Trial website | http://www.easttrial.org |
| Publications | 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21784740 |
| Contact name | Prof Paulus Kirchhof |
| Address |
c/o Elisabeth Freund
Projektmanagement CRI - The Clinical Research Institute GmbH Arnulfstraße 19 |
| City/town | München |
| Zip/Postcode | 80335 |
| Country | Germany |
| Sponsor | German Atrial Fibrillation Network (Germany) |
| Address | Domagkstr. 11 |
| City/town | Münster |
| Zip/Postcode | 48149 |
| Country | Germany |
| Sponsor website: | http://www.kompetenznetz-vorhofflimmern.de |
| Date applied | 07/12/2010 |
| Last edited | 24/11/2011 |
| Date ISRCTN assigned | 10/01/2011 |
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