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 deathstroke 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
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