EMA Issues Draft Guidance for Stroke Prevention in AF Patients

EMA provides guidance on development of medicines to prevent stroke in patients with atrial fibrillation – comments invited

The European Medicines Agency has released a draft guideline on clinical investigation of medicines for the prevention of stroke and systemic embolic events in patients with non-valvular atrial
fibrillation
for public consultation.

The document aims to provide specific guidance on stroke prevention, an aspect that is not covered in the existing guidelines.

Comments should be sent by 15 January 2014 to cvswpsecretariat@ema.europa.eu, using the template provided. 

Atrial fibrillation is the most common form of sustained cardiac arrhythmia, occurring in 1–2% of the general population, and carries with it a five-fold increased risk of stroke. One in five of all strokes is attributed to this arrhythmia.

The aim is to provide guidance to industry and other medicines developers performing trials with medicines for the prevention of stroke and systemic embolic events in patients with atrial fibrillation not linked to heart valve disorders.

The document provides guidance on:

  • criteria for the assessment of efficacy;
  • methods to assess efficacy;
  • criteria for the selection of patients;
  • strategy for trial design;
  • safety aspects.

Posted: November 2013

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