Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST)
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Purpose
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 2010 ESC guidelines for AF treatment. Early rhythm control therapy will be guided by ECG monitoring.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Stroke |
Other: early standardised rhythm control |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST). |
- A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
The 1st co-primary outcome parameter is defined as the time to the first occurrence of a composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary.
The 2nd co-primary outcome is nights spent in hospital per year.
- Cardiovascular death [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- stroke [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- worsening of heart failure [ Time Frame: 6 years ] [ Designated as safety issue: No ]assessed by hospitalizations
- acute coronary syndrome [ Time Frame: 6 years ] [ Designated as safety issue: No ]assessed by hospitalizations
- time to recurrent atrial fibrillation [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- cardiovascular hospitalisations [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- all-cause hospitalisations [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- left ventricular function assessed by transthoracic echocardiography [ Time Frame: at month 24 after randomisation ] [ Designated as safety issue: No ]
- quality of life changes assessed by EQ-5D and SF-12 [ Time Frame: at month 24 after randomisation ] [ Designated as safety issue: No ]
- cognitive function assessed by MoCA [ Time Frame: at month 24 after randomisation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2810 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Usual care
Usual care closely follows the suggestions laid out in the 2010 ESC guidelines for AF. In addition to antithrombotic therapy and therapy of underlying heart disease, usual care usually consists of an initial attempt to control symptoms by rate control therapy. Rhythm control interventions are recommended when symptoms can not be controlled by optimal rate control therapy in the usual care group.
|
|
|
Early therapy
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:
All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences. |
Other: early standardised rhythm control
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:
All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recent-onset AF (≤ 1 year prior to enrolment)
- At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 sec.
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.
- Provision of signed informed consent.
- Age ≥ 18 years.
Exclusion Criteria:
- Any disease that limits life expectancy to less than 1 year.
- Participation in another clinical trial, either within the past two months or ongoing
- Previous participation in the EAST trial.
- 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.
- Breastfeeding women.
- Drug abuse.
- Prior AF ablation or surgical therapy of AF.
- Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone.
- Patients not suitable for rhythm control of AF.
- Severe mitral valve stenosis.
- Prosthetic mitral valve.
- Clinically relevant hepatic dysfunction requiring specific therapy.
- Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
- Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 10 ml/min).
Contacts and Locations| Contact: Paulus Kirchhof, MD | +44 121 507 50 80 | p.kirchhof@bham.ac.uk |
| Contact: Sabine Jürgensmeyer, PhD | +49 251 834 76 24 | sabine.juergensmeyer@ukmuenster.de |
| Belgium | |
| Recruiting | |
| Aalst, Belgium | |
| Czech Republic | |
| Recruiting | |
| Praha, Czech Republic | |
| Germany | |
| Recruiting | |
| Hamburg, Germany | |
| Italy | |
| Not yet recruiting | |
| Acquaviva delle Fonti, Italy | |
| Netherlands | |
| Recruiting | |
| Zutphen, Netherlands | |
| Poland | |
| Recruiting | |
| Warsaw, Poland | |
| Spain | |
| Recruiting | |
| Barcelona, Spain | |
| United Kingdom | |
| Not yet recruiting | |
| Birmingham, United Kingdom | |
| Principal Investigator: | Paulus Kirchhof, MD | University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham B187QH |
More Information
Additional Information:
No publications provided
| Responsible Party: | German Atrial Fibrillation Network |
| ClinicalTrials.gov Identifier: | NCT01288352 History of Changes |
| Other Study ID Numbers: | 2010-021258-20 |
| Study First Received: | February 1, 2011 |
| Last Updated: | January 9, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by German Atrial Fibrillation Network:
|
early treatment rhythm control atrial fibrillation cardiovascular complications |
Additional relevant MeSH terms:
|
Atrial Fibrillation Stroke Cerebral Infarction Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Brain Infarction Brain Ischemia Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013