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Early Treatment of Atrial Fibrillation for Stroke Prevention Trial

Information source: German Atrial Fibrillation Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation; Stroke

Intervention: early standardised rhythm control (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: German Atrial Fibrillation Network

Official(s) and/or principal investigator(s):
Paulus Kirchhof, MD, Principal Investigator, Affiliation: University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham B187QH

Overall contact:
Paulus Kirchhof, MD, Phone: +44 121 507 50 80, Email: p.kirchhof@bham.ac.uk

Summary

EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care. Patients will be randomized to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. 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 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (ECG) monitoring.

Clinical Details

Official title: Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST).

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome.

Secondary outcome:

Cardiovascular death

stroke

worsening of heart failure

acute coronary syndrome

time to recurrent atrial fibrillation

cardiovascular hospitalisations

all-cause hospitalisations

left ventricular function assessed by transthoracic echocardiography

quality of life changes assessed by EQ-5D and SF-12

cognitive function assessed by MoCA

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Recent-onset AF (≤ 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 sec. 3. One of the following:

- age > 75 years or

- prior stroke or transient ischemic attack

OR two of the following:

- age > 65 years,

- female sex,

- arterial hypertension (chronic treatment for hypertension, estimated need for

continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg),

- diabetes mellitus (treated by drugs or insulin) or impaired glucose tolerance

- severe coronary artery disease (previous myocardial infarction, CABG or PCI)

- stable heart failure (NYHA II or LVEF <50%),

- left ventricular hypertrophy on echocardiography (more than 15 mm wall

thickness),

- chronic kidney disease (MDRD stage III or IV),

- peripheral artery disease.

4. Provision of signed informed consent. 5. Age ≥ 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 randomized. 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) < 10 ml/min).

Locations and Contacts

Paulus Kirchhof, MD, Phone: +44 121 507 50 80, Email: p.kirchhof@bham.ac.uk

12 Sites, Different, Belgium; Recruiting

3 Sites, Different, Czech Republic; Recruiting

2 Sites, Different, Denmark; Recruiting

2 Sites, Different, France; Recruiting

39 Sites, Different, Germany; Recruiting

11 Sites, Different, Italy; Recruiting

9 Sites, Different, Netherlands; Recruiting

5 Sites, Different, Poland; Recruiting

9 Sites, Different, Spain; Recruiting

4 Sites, Different, Switzerland; Recruiting

22 Sites, Different, United Kingdom; Recruiting

Additional Information

official web page for the EAST trial

Starting date: February 2011
Last updated: July 6, 2015

Page last updated: August 23, 2015

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