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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Sanofi
Abbott
Information provided by (Responsible Party):
German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:
NCT01288352
First received: February 1, 2011
Last updated: February 3, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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: 8 years ]

    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: 8 years ]
  • stroke [ Time Frame: 8 years ]
  • worsening of heart failure [ Time Frame: 8 years ]
    assessed by hospitalizations

  • acute coronary syndrome [ Time Frame: 6 years ]
    assessed by hospitalizations

  • time to recurrent atrial fibrillation [ Time Frame: 8 years ]
  • cardiovascular hospitalisations [ Time Frame: 8 years ]
  • all-cause hospitalisations [ Time Frame: 8 years ]
  • left ventricular function assessed by transthoracic echocardiography [ Time Frame: at month 24 after randomisation ]
  • quality of life changes assessed by EQ-5D and SF-12 [ Time Frame: at month 24 after randomisation ]
  • cognitive function assessed by MoCA [ Time Frame: at month 24 after randomisation ]

Enrollment: 2789
Study Start Date: February 2011
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: June 2019 (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 current European Society of Cardiology (ESC) guidelines for AF treatment. 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 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 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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).
  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

Locations
Belgium
14 Sites
Different, Belgium
Czech Republic
4 Sites
Different, Czech Republic
Denmark
2 Sites
Different, Denmark
France
2 Sites
Different, France
Germany
51 Sites
Different, Germany
Italy
12 Sites
Different, Italy
Netherlands
13 Sites
Different, Netherlands
Poland
5 Sites
Different, Poland
Spain
10 Sites
Different, Spain
Switzerland
5 Sites
Different, Switzerland
United Kingdom
22 Sites
Different, United Kingdom
Sponsors and Collaborators
German Atrial Fibrillation Network
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Sanofi
Abbott
Investigators
Principal Investigator: Paulus Kirchhof, MD University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham B187QH
  More Information

Additional Information:
Publications:
International Landmark EAST Study Inverstigates Treatment Options for Atrial Fibrillation

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: AFNET 4 EAST
2010-021258-20 ( EudraCT Number )
Study First Received: February 1, 2011
Last Updated: February 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by German Atrial Fibrillation Network:
early treatment
rhythm control
atrial fibrillation
cardiovascular complications

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on August 18, 2017