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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288352
First Posted: February 2, 2011
Last Update Posted: February 6, 2017
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.
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Sanofi
Abbott
Information provided by (Responsible Party):
Atrial Fibrillation Network
February 1, 2011
February 2, 2011
February 6, 2017
February 2011
June 2019   (Final data collection date for primary outcome measure)
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.

A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome. [ Time Frame: 6 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.

Complete list of historical versions of study NCT01288352 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Cardiovascular death [ Time Frame: 6 years ]
  • stroke [ Time Frame: 6 years ]
  • worsening of heart failure [ Time Frame: 6 years ]
    assessed by hospitalizations
  • acute coronary syndrome [ Time Frame: 6 years ]
    assessed by hospitalizations
  • time to recurrent atrial fibrillation [ Time Frame: 6 years ]
  • cardiovascular hospitalisations [ Time Frame: 6 years ]
  • all-cause hospitalisations [ Time Frame: 6 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 ]
Not Provided
Not Provided
 
Early Treatment of Atrial Fibrillation for Stroke Prevention Trial
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Stroke
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.

  • 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.

    Intervention: Other: early standardised rhythm control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2789
November 2019
June 2019   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
Turkey
 
NCT01288352
AFNET 4 EAST
2010-021258-20 ( EudraCT Number )
Yes
Not Provided
Plan to Share IPD: Undecided
Atrial Fibrillation Network
Atrial Fibrillation Network
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • Sanofi
  • Abbott
Principal Investigator: Paulus Kirchhof, MD University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham B187QH
Atrial Fibrillation Network
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP