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Regulatory Focus™ > News Articles > EMA Releases Guideline on Conducting Clinical Trials for Atrial Fibrillation Products

EMA Releases Guideline on Conducting Clinical Trials for Atrial Fibrillation Products

Posted 15 August 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has released a new guideline for sponsors of products to prevent strokes in patients with non-valvular atrial fibrillation (AF).

EMA notes the guideline fills a void left by other guidance documents on antiarrhythmics used to prevent AF, which do not address stroke prevention and systemic embolic events (SEE). The new guideline is specifically aimed at assisting sponsors in the clinical testing of such products, regulators said.

Non-valvular AF is characterized by an irregular heartbeat in the absence of rheumatic disease of the heart's mitral valve or a prosthetically or surgically repaired mitral valve. EMA notes all forms of AF effect approximately 6 million Europeans, with rates expected to double in the next half century. Strokes in those suffering from AF are often fatal, and those who survive are often left more incapacitated than those without AF.

Reducing the Risk of Stroke

Sponsors of Phase III clinical trials in this area should be able to demonstrate that their product decreases the number of strokes and SEEs in enrolled patients, explained EMA.

EU regulators also said patients should be assessed before the start of the trial for their risk of stroke using an assessment process that takes into account the patient's cardiac failure, hypertension, age, diabetes and prior stroke (CHADS). If patients have a stroke during the course of the trial, the outcome of the stroke should assessed to include whether it was a disabling stroke, a transient ischemic attack, a heart attack, or if there was vascular death, all-cause death or a pulmonary embolism.

The end result of a successful trial should show the product reducing a patient's risk of ischemic and hemorrhagic strokes, explained EMA, and include at least thirty days of follow-up after the last administration of the drug.

Read more:

EMA - 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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