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

Phase 4

Completed

Conditions: Atrial fibrillation. i.e. the heart's upper chambers (the atria) beating very rapidly and irregularly
resulting in an irregular pulse
10007521

Registration Number: NL-OMON41351

Lead Sponsor: Kompetenznetz Vorhofflimmern e.V., AFNET e.V., Germany

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 230

Inclusion Criteria

1. Recent onset AF, i.e. AF with a known history of <= 1 year prior to randomisation
2. Risk for stroke as evidenced by
EITHER
a) one of the following: age > 75 years, prior stroke or transient ischemic attack (TIA)
OR
b) 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), stable heart
failure (NYHA II or LVEF <50%), severe coronary artery disease (previous myocardial infarction, CABG or PCI)

Exclusion Criteria

1. prior AF ablation or surgical therapy of AF
2. patients not suitable for rhythm control of AF
3. severe mitral valve stenosis
4. prosthetic mitral valve

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A composite of cardiovascular death, stroke / transient ischemic attack (TIA),<br /><br>and hospitalization due to worsening of heart failure or due to acute coronary<br /><br>syndrome.<br /><br>The 1st co-primary outcome parameter is defined as the time to the first<br /><br>occurrence of a composite of the above mentioned components. The 2nd co-primary<br /><br>outcome is nights spent in hospital per year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Several secondary outcomes will be assessed in the study population. Key<br /><br>secondary outcomes: Each of the components of the primary outcome, time to<br /><br>recurrent AF, cardiovascular hospitalizations, all-cause hospitalizations, left<br /><br>ventricular function, quality of life, cognitive function, cost of therapy.<br /><br>These and additional secondary outcome parameters will be assessed in the main<br /><br>trial and in investigator driven sub-studies.<br /><br>Assessment of safety: The primary safety outcome comprises all deaths, the<br /><br>components of the primary efficacy parameter plus other adverse events related<br /><br>to the study intervention with special emphasis on proarrhythmia and<br /><br>complications due to interventions.</p><br>