Clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation - Scientific guideline

This document provides guidance on the conduct of trials to develop medicinal products in prevention of stroke and systemic embolic events in patients with non-valvular artial fibrillation.

Keywords: Stroke, systemic embolism, atrial fibrillation, anticoagulant

Current effective version

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

Adopted Consultation dates: 15/07/2014 to 15/10/2014 Reference Number: EMA/CHMP/341363/2014 Legal effective date: 26/12/2014 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.

Document history

Overview of comments received on '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/341511/2014

Second 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 closed Consultation dates: 15/11/2013 to 15/01/2014 Reference Number: EMA/CHMP/623942/2013 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.

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 closed Consultation dates: 15/08/2012 to 15/02/2013 Reference Number: EMA/CHMP/450916/2012 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. 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.

Concept paper on the need for a guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with atrial fibrillation

Draft: consultation closed Consultation dates: 17/02/2011 to 31/05/2011 Reference Number: EMA/CHMP/68875/2011