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Contact Information:

Prof Paulus Kirchhof


Study Location:

CRI - The Clinical Research Institute GmbH
München
80335


Early treatment of atrial fibrillation for stroke prevention trial

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Recent onset atrial fibrillation/stroke risk


Study summary

Background and study aims
Atrial fibrillation is a heart condition that results in an irregular, often abnormally fast heart rate, which also increases the risk of having a stroke. It can be treated with anti-arrhythmic drugs that restore a normal heart rhythm and rate. It can also be treated with catheter ablation, a procedure where the diseased area of the heart is very carefully destroyed to interrupt the fast, irregular electrical impulses. The aim of this study is to find out whether early, structured rhythm control treatment using anti-arrhythmic drugs and catheter ablation can prevent complications (e.g., stroke) in patients with atrial fibrillation.

Who can participate?
Patients aged 18 and over who have had atrial fibrillation for a year or less and are at high risk of stroke

What does the study involve?
Patients are randomly allocated to receive early treatment or usual care. In the early treatment group, patients receive either catheter ablation or anti-arrhythmic drug treatment at an early timepoint. The initial treatment is selected by the doctor. If atrial fibrillation returns both treatments are combined. Usual care follows the current guidelines for atrial fibrillation treatment. All patients are followed up every 6 months by questionnaire and by outpatient follow-up visits at 12, 24 and 36 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
CRI - The Clinical Research Institute GmbH (Germany)

When is the study starting and how long is it expected to run for?
July 2011 to December 2019

Who is funding the study?
German Atrial Fibrillation Network (Germany)

Who is the main contact?
Prof Paulus Kirchhof

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 current ESC guidelines for AF treatment. Early rhythm control therapy will be guided by ECG monitoring.


Phase IV randomised open prospective two-armed parallel-group multicentre trial

Key dates

The recruitment start and end dates are as follows:

01 Jul 2011

31 Dec 2016

Publications

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/217847402013 rationale and design in: http://www.ncbi.nlm.nih.gov/pubmed/240164922015 article in: http://www.ncbi.nlm.nih.gov/pubmed/25646394

Study type

Interventional

Intervention Type : Drug
Intervention Name :
Intervention Description : Usual care group:Usual care closely follows the suggestions laid out in the current 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 cannot 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 8 years is expected. All patients will be followed-up until the end of the trial with a minimum follow-up period of two and a half years.


Who can take part?

You can take part if:


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 seconds3. One of the following:3.1. Aged greater than 75 years, or3.2. Prior stroke or transient ischaemic attackOR two of the following:3.3. Aged greater than 65 years3.3. Female sex3.4. Arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure greater than 145/90 mmHg)3.5. Diabetes mellitus3.6. 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 disease4. Provision of signed informed consent5. Age greater than or equal to 18 years




You may not be able to take part if:

1. Any disease that limits life expectancy to less than 1 year2. Participation in another clinical trial, either within the past two months or ongoing3. Previous participation in the EAST trial4. 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 randomised5. Breastfeeding women6. Drug abuse7. Prior AF ablation or surgical therapy of AF8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone9. Patients not suitable for rhythm control of AF10. Severe mitral valve stenosis11. Prosthetic mitral valve12. Clinically relevant hepatic dysfunction requiring specific therapy13. 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)


Where can I take part?

Below are the locations for where you can take part in the trial.

  • CRI - The Clinical Research Institute GmbH
    München
    80335

Contact information

Prof Paulus Kirchhof


Funders/Sponsors


The study is sponsored by German Atrial Fibrillation Network (Germany) and funded by German Atrial Fibrillation Network (Germany) .



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for Trial ID: ISRCTN04708680

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