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

July 21, 2020 updated by: Atrial Fibrillation Network

Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2789

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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 (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atrial Fibrillation Network

Collaborators

Sanofi
Abbott
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Deutsche Herzstiftung e.V.
European Heart Rhythm Association (EHRA)
BMBF (German Ministry for Science)

Investigators

  • Principal Investigator: Paulus Kirchhof, MD, University of Birmingham Centre for Cardiovascular Sciences, Department of Cardiology, University Heart and Vascular Center UKE Hamburg, Hamburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

March 6, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAST- AFNET 4
  • 2010-021258-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

We will make data available starting six months after the publication of the primary results for 5 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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