Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by German Atrial Fibrillation Network
Sponsor:
Information provided by (Responsible Party):
German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:
NCT01288352
First received: February 1, 2011
Last updated: February 20, 2014
Last verified: February 2014
  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 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (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).

Resource links provided by NLM:


Further study details as provided by German Atrial Fibrillation Network:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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:

  1. Optimal antiarrhythmic drug therapy (Dronedarone, Amiodarone, Flecainide, Propafenone),
  2. Catheter ablation with the aim of pulmonary vein isolation (PVI),
  3. Antiarrhythmic 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.

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:

  1. Optimal antiarrhythmic drug therapy
  2. Catheter ablation with the aim of pulmonary vein isolation (PVI),
  3. Antiarrhythmic drug therapy and catheter ablation may be combined and 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288352

Contacts
Contact: Paulus Kirchhof, MD +44 121 507 50 80 p.kirchhof@bham.ac.uk
Contact: Gerlinde Benninger +49 251 8345340

Locations
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
Sponsors and Collaborators
German Atrial Fibrillation Network
Investigators
Principal Investigator: Paulus Kirchhof, MD University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham B187QH
  More Information

Additional Information:
No publications provided by German Atrial Fibrillation Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: February 20, 2014
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 July 29, 2014