Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial) : The Lancet
The Lancet - Early Online Publication, 06/15/2012
Davalos A et al. – Under the circumstances of the ICTUS trial, citicoline is not efficacious in the treatment of moderate–to–severe acute ischaemic stroke.
- The authors undertook a randomised, placebo-controlled, sequential trial in patients with moderate-to-severe acute ischaemic stroke admitted at university hospitals in Germany, Portugal, and Spain.
- Using a centralised minimisation process, patients were randomly assigned in a 1:1 ratio to receive citicoline or placebo within 24 h after the onset of symptoms (1000 mg every 12 h intravenously during the first 3 days and orally thereafter for a total of 6 weeks [2×500 mg oral tablets given every 12 h]).
- All study participants were masked.
- The primary outcome was recovery at 90 days measured by a global test combining three measures of success: National Institutes of Health Stroke Scale ≤1, modified Rankin score ≤1, and Barthel Index ≥95.
- Safety endpoints included symptomatic intracranial haemorrhage in patients treated with recombinant tissue plasminogen activator, neurological deterioration, and mortality.
- 2298 patients were enrolled into the study from Nov 26, 2006, to Oct 27, 2011.
- 37 centres in Spain, 11 in Portugal, and 11 in Germany recruited patients.
- Of the 2298 patients who gave informed consent and underwent randomisation, 1148 were assigned to citicoline and 1150 to placebo.
- The trial was stopped for futility at the third interim analysis on the basis of complete data from 2078 patients.
- The final randomised analysis was based on data for 2298 patients: 1148 in citicoline group and 1150 in placebo group.
- Global recovery was similar in both groups (odds ratio 1.03, 95% CI 0.86-1.25; p=0.364).
- No significant differences were reported in the safety variables nor in the rate of adverse events.