BioCentury
ARTICLE | Politics & Policy

EMA issues draft guidance on stroke prevention in AF

November 19, 2013 1:57 AM UTC

EMA issued draft guidance on conducting trials for products to prevent stroke and systemic embolic events in patients with non-valvular atrial fibrillation (AF). The guidance recommends that trials have a composite primary endpoint of time to first stroke, including ischemic and undefined strokes, and systemic embolic events, and that sponsors evaluate the components of the composite endpoint separately for secondary endpoints. Other recommended secondary endpoints include all strokes, all major bleedings and all-cause death, which the guidance notes evaluate net clinical benefit and "can be of value in the risk-benefit assessment." On safety, the guidance also recommends assessing the risk of bleeding via the composite bleeding endpoints of clinically relevant bleeding, non-major bleeding and total bleeding. Comments are due Jan. 15. ...