The large personal, social, and economic burden of stroke in Europe is largely determined by its frequent occurrence in the elderly, a group seriously underrepresented in most previous stroke treatment trials. Elderly patients are also at the highest risk of developing complications, such as infections and fever. The occurrence of these complications in the first days after stroke leads to longer hospital stays and higher costs, and is independently associated with an increased risk of death or long-term dependency.
We believe that pharmacological prevention of common complications in elderly patients with acute stroke is therefore likely to reduce the risk of death and to improve functional outcomes. Current stroke guidelines recommend the treatment of complications only once they have become manifest, and such treatments are often started late or not at all.
To address this, our key objectives are:
1. To perform a pragmatic, randomised, controlled, open clinical trial with blinded outcome assessment in 3800 patients aged 66 years or older with acute ischaemic stroke or intracerebral haemorrhage, recruited from 80 centres in 9 European countries.
2. In this trial, to assess the effects of preventive treatment with high-dose paracetamol, ceftriaxone, and metoclopramide on a comprehensive array of relevant health outcomes, including survival, functional outcome, quality of life, and cognition. This treatment strategy is simple but innovative because these drugs will be used for the prevention of complications, whereas these are currently recommended for their treatment.
3. To perform subgroup analyses based on age, sex, stroke severity, comorbidities, and geographic region, to detect specific populations in which the proposed treatments are particularly effective or not effective, to allow treatment to be tailored to specific patient groups.