PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment

Every year, 1.3 million Europeans have a first stroke. One fifth to one third of stroke patients die in the first month after stroke, and one third remain dependent on the help of others. The annual costs for stroke care in Europe have been estimated at €64.1 billion. Stroke incidence increases almost exponentially with age, and the personal, societal, and economic burden of stroke is therefore largely driven by its frequent occurrence in the elderly. Elderly patients are at the highest risk of complications after stroke, such as infections and fever. These complications are strongly and independently associated with a higher risk of death or dependency. The risk of developing these complications can be reduced by very simple, safe, and cheap measures, such as metoclopramide for the management of dysphagia, antibiotics for the prevention of infections, and paracetamol for the prevention of fever, but it is uncertain whether these measures also improve functional outcome.

PRECIOUS will assess whether a pharmacological strategy to prevent common complications in elderly patients with acute stroke is more effective at reducing the risk of death and improving functional outcome than current clinical practice – recommended in guidelines – of waiting until these complications are manifest before initiating treatment.