I-Stroke II is an academic driven, multicentre, prospective, randomised, double-blind, parallel-group, placebo-controlled, multicentre efficacy trial of Imatinib in acute ischaemic stroke.
Population: Patients with acute ischemic stroke within 8 hours or symptom onset with a neurological deficit corresponding to 6 points or higher on the National Institutes of Health Stroke Scale (NIHSS) score
Intervention: TabletImatinib 800 mg per day orally for 6 days
Control: Matching placebo-treated group, randomized between Imatinib and placebo.
Outcome: Functional outcome scale at 3 months after treatment initiation using the mRS
Hypothesis
Imatinib with a dose of 800 mg per day for 6 days reduces neurological disability and improves long-term functional outcome after acute ischemic stroke
Primary Objectives
To investigate if Imatinib (800 mg / day) treatment initiated within 8 hours of symptom onset and given for 6 days improves functional outcome at three months after acute ischaemic stroke