Third International Stroke Trial in Norway

Thrombolytic treatment for acute stroke has recently been licensed for use in a few, highly selected patients, and under strict regulatory conditions. IST-3 is an independent international randomised-controlled trial designed to provide more reliable data on the effects of thrombolytic treatment, in a wide ranger of patients (target recruitment 6,000). Patients with acute stroke will be randomised within 6 hours of onset to intravenous recombinant tissue plasminogen activator (rt-PA) 90 mg/kg or open cont rol. The Norwegian Stroke Study Group (Lancet 2000;355:1205) wishes to participate in IST-3 (Objective 1 below), and, in addition, to: assess patients’ relative preferences for different outcomes after stroke (Objective 2); evaluate the organisational ba rriers to thrombolytic treatment for acute stroke in Norway (Objective 3); and estimate the cost-effectiveness of thrombolytic treatment (Objective 4). IST-3 Norway will be set up very cost-effectively, by capitalising on the existing expertise of the IST -3 co-ordinating centre in Edinburgh , the Norwegian Stroke Study Group, and Center of Health Economics, University of Oslo. The start-up phase of IST-3 Norway commenced in November 2002, and has been successful in reaching the targets specified in the o riginal applications. After 18 months of recruitment, 38 patients have been randomised at three centres, and another 5 centres are now ready to participate in the expansion phase of the trial. Considerable progress has also been made with the three specif ic Norwegian projects mentioned above. The start-up phase has demonstrated that thrombolysis for acute stroke is feasible in Norway, and holds the promise that the study in 2005 can be expanded to a larger scale. We therefore recommend that ‘IST-3 Norway’ should continue, and that that funding for the expancion phase of the trial should be released.