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

STUDY TITLE
Early Treatment of Atrial Fibrillation for Stroke
Prevention Trial (EAST)
SPONSOR
TRIAL LOCATION
FUNDER
CHIEF INVESTIGATOR
STUDY DESIGN
University of Leicester
11 European Countries
Kompetenznetz Vorhofflimmern
Professor G Andre Ng
An Investigator-driven, Prospective, Parallel-group, Randomized, Open,
Blinded Outcome Assessment (PROBE design), Multi-centre Trial
To test whether an early, comprehensive, rhythm control therapy can
prevent adverse cardiovascular outcomes in patients with recent-onset
atrial fibrillation (AF) compared to usual care.
Approximately 200 study sites including 40-50 ablation sites
2,810 patients to be randomized.
Ongoing
The following main criteria must be present for eligibility into the study:
- Recent onset AF (≤ 1 year prior to randomisation)
- At least one ECG within 12 months that documents the AF
episode lasting longer than 30 seconds
- Patient is 18 years or older
- One of the following risk factors: age > 75 years, prior stroke or
transient ischemic attack (TIA) OR
- Two of the following risk factors: hypertension, diabetes mellitus,
left ventricular hypertrophy, age > 65 years, female sex,
peripheral artery disease, kidney disease (MDRD stage III or IV), a
stable heart failure (NYHA II OR IVEF <50%), severe coronary
artery disease (previous myocardial infarction, CABG or PCI)
- Patients not suitable for rhythm control of AF
- Prior AF ablation
Previous therapy failure on amiodarone
- Prior surgical therapy of AF
- Severe mitral value stenosis
- Prosthetic mitral value
- Clinically relevant hepatic dysfunction requiring specific therapy
- Severe renal dysfunction (Stage V, requiring or almost requiring
dialysis)
- Clinically manifest thyroid dysfunction requiring therapy. After
successful treatment of thyroid dysfunction, patients may be
enrolled when their thyroid function is controlled
- Participant in another clinical trial stopped ≤ two months ago or
ongoing
- Any disease that limits life expectancy to less than 1 year
Conduct a search to identify potentially eligible patients
GP to check patient list from the search
Support with search and/or mailing
An estimated NHS Service support cost payment of £200.00 has been
calculated for this study.
(This figure is based upon the information provided by the study team regarding the likely activities
STUDY OBJECTIVE
PRACTICE TARGET &
RECRUITMENT TARGET
RECRUITMENT PERIOD
INCLUSION CRITERIA
(A Research Facilitator will
support your practice to
conduct the search)
EXCLUSION CRITERIA
PRACTICE INVOLVEMENT
CRN-PC SUPPORT
SERVICE SUPPOT COST
to be performed by your Practice. It is an approximation only and may be adjusted in line with the
amount of patient recruitment and the level of CRN support received )
STUDY FLOW CHART
Recent onset atrial fibrillation (First diagnosis ≤ 1 year ago)
AND
At risk for cardiovascular events, i.e. CHADSVASc score ≥ 2
CHADSVASc Criteria:
One of the following: age > 75 years or prior stroke /TIA
OR
Two of the following: hypertension, diabetes mellitus, left
ventricular hypertrophy, age > 65 years, female sex, peripheral
artery disease, kidney disease (MDRD stage III or IV), a stable
heart failure (NYHA II OR IVEF <50%), severe coronary artery
disease (previous myocardial infarction, CABG or PCI)
Randomisation (1:1)
USUAL CARE
EARLY RHYTHM CONTROL
Antocoagulation, rate control,
supplemented by rhythm control
only in symptomatic patients on
optimal rate control therapy
Anticoagulation, rate control if required,
and antiarrhythmic drug therapy and/or AF
ablation
2x weekly patient-led handheld ECG
monitoring of therapy +/- appropriate
agreed additional intervention if AF recurs
Outpatient FU at 12, 24, 36 months
Blinded assessment of primary outcomes