CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,789 enrolled
Drug / intervention
early standardised rhythm controlother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01288352
NCT01288352Phase 4Completed

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

Atrial Fibrillation Network·interventional·Posted Feb 2, 2011·Updated Jul 23, 2020

In Brief

A Phase 4 clinical trial evaluating early standardised rhythm control for Atrial Fibrillation and Stroke. Completed, enrolled 2,789 participants across 11 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2011
Enrollment StartJul 1, 2011
Primary CompletionMar 6, 2020
Study CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 15.4 years ago

Interventions

early standardised rhythm controlother

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.