Early Treatment of Atrial Fibrillation for Stroke Prevention Trial "EAST"

Recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Early standardised rhythm control Other
    Intervention Desc: 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: Optimal antiarrhythmic drug therapy Catheter ablation with the aim of pulmonary vein isolation (PVI), 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.
    ARM 1: Kind: Experimental
    Label: Early therapy
    Description: 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: Optimal antiarrhythmic drug therapy (Dronedarone, Amiodarone, Flecainide, Propafenone), Catheter ablation with the aim of pulmonary vein isolation (PVI), 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.
    ARM 2: Kind: Experimental
    Label: early standardised rhythm control
    Description: 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: Optimal antiarrhythmic drug therapy (Dronedarone, Amiodarone, Flecainide, Propafenone), Catheter ablation with the aim of pulmonary vein isolation (PVI), 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome. 6 years No
Secondary Cardiovascular death 6 years No
Secondary stroke 6 years No
Secondary worsening of heart failure 6 years No
Secondary acute coronary syndrome 6 years No
Secondary time to recurrent atrial fibrillation 6 years No
Secondary cardiovascular hospitalisations 6 years No
Secondary all-cause hospitalisations 6 years No
Secondary left ventricular function assessed by transthoracic echocardiography at month 24 after randomisation No
Secondary quality of life changes assessed by EQ-5D and SF-12 at month 24 after randomisation No
Secondary cognitive function assessed by MoCA at month 24 after randomisation No

Sponsors