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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01288352
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
Sanofi
Abbott
Deutsche Herzstiftung e.V.
European Heart Rhythm Association (EHRA)
BMBF (German Ministry for Science)
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Atrial Fibrillation Network

Brief 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Other: early standardised rhythm control Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2789 participants
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).
Actual Study Start Date : July 1, 2011
Actual Primary Completion Date : March 6, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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 syndrome. The second co-primary outcome is nights spent in hospital per year.

    The 2nd co-primary outcome is nights spent in hospital per year.



Secondary Outcome Measures :
  1. Key 2d outcomes: Each of the components of the 1st outcome, time to recurrent AF, cv hospitalizations, all-cause hospitalizations, left ventricular function, QL, cognitive function, cost of therapy. [ Time Frame: 8 years ]

    The 2d outcome parameters are defined as

    -all-cause death, AF-related death, time to the 1. occurrence of each of the components of the 1st co-primary outcome, time to recurrent AF (paroxysmal, persistent, long-lasting persistent, permanent) ,AF burden,time to 1. therapy change, time to 1. cv hosp., nr of cv hosp., left ventricular function at 24 months, QoL changes at 24 months and at study termination comp. to baseline, health-related cost calculation and cost of outpatient treatment, change of cognitive function at 24 months compared to BL, cardiac rhythm (sinus rhythm vs. AF), time to: -first symptomatic AF recurrence, -first progression of AF (from paroxysmal to persistent or long-lasting persistent or permanent and each of these components).

    The 1st safety outcome:all deaths, the components of the 1st efficacy parameter plus other AEs rel. to the study intervention with special emphasis on proarrhythmia and complications due to interventions.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288352


Locations
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Belgium
14 Sites
Different, Belgium
Czechia
4 Sites
Different, Czechia
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
Atrial Fibrillation Network
Sanofi
Abbott
Deutsche Herzstiftung e.V.
European Heart Rhythm Association (EHRA)
BMBF (German Ministry for Science)
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Principal Investigator: Paulus Kirchhof, MD University of Birmingham Centre for Cardiovascular Sciences, Department of Cardiology, University Heart and Vascular Center UKE Hamburg, Hamburg, Germany
Additional Information:
Publications of Results:
International Landmark EAST Study Inverstigates Treatment Options for Atrial Fibrillation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT01288352    
Other Study ID Numbers: EAST- AFNET 4
2010-021258-20 ( EudraCT Number )
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

We will share all data that support published results of the trial. Additional data that have not been published will be withheld until six months after publication of these results.

Data will be made available as required for specific, approved analyses. Data will be provided from locked, cleaned and de-identified study database. Requests will be reviewed by AFNET as per the predefined subanalysis plan.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: We will make data available starting six months after the publication of the primary results for 5 years.
Access Criteria:

The Clinical Study Report (CSR) and the Analytic Code will be shared upon request to AFNET.

This plan and the contact details will be made available on the EAST web site (www.easttrial.org) with additional information on planned and ongoing subanalyses conducted within the EAST trial team.

Keywords provided by Atrial Fibrillation Network:
early treatment
rhythm control
atrial fibrillation
cardiovascular complications
Additional relevant MeSH terms:
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Atrial Fibrillation
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes