Scientific guideline: Draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation, draft: consultation open
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. The current note for guidance on antiarrhythmics (CPMP/EWP/237/95) and its addendum on atrial fibrillation and flutter (EMA/CHMP/EWP/213056/2010) do not cover stroke prevention. The aim of this guideline is to provide guidance to industry when performing trials to develop drugs in prevention of stroke and systemic embolic events in patients with AF.
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