Second draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation

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Download document Second draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation
Reference number EMA/CHMP/623942/2013
Status draft: consultation open
First published 15/11/2013
Last updated 15/11/2013
Consultation start date 15/11/2013
Consultation end date 15/01/2014
Email address for submissions cvswpsecretariat@ema.europa.eu

Summary

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1–2% of the general population. AF confers a 5-fold risk of stroke, and one in five of all strokes is attributed to this arrhythmia.