Imatinib Treatment in Acute Ischemic Stroke

Conditions: Acute ischaemic stroke
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-019014-25-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Clinical diagnosis of ischaemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischaemic stroke is defined as an event characterised by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischaemia, after CT scan exclusion of haemorrhage

-Neurological deficit is corresponding to 7 points or higher on the National Institutes of Health Stroke Scale (NIHSS)

-Age 18 – 85 years

-Symptoms must be distinguishable from an episode of generalised ischaemia (i.e. syncope), seizure, or migraine disorder

-Intravenous thrombolysis is indicated on clinical grounds and has been initiated within 4.5 hours of stroke onset

-Patients can be randomised to active treatment or control as soon as possible but at least within one hour after completion of intravenous thrombolysis, or if applicable, after completion of additional intraarterial intervention

-Patients has provided informed consent with regard to participation in the study, retrieval and storage of data and follow up procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

-Evidence of intracranial haemorrhage (including haemorrhagic transformation or intracerebral haemorrhage) on the baseline CT-scan

-Severe stroke as assessed clinically (e.g. NIHSS>25) and/or developing infarct extending into more than 1/3 of the Middle Cerebral Artery territory or ½ of other vascular territories

-Administration of heparin within the previous 48 hours preceding the onset of stroke with an elevated activated thromboplastin time (aPTT) at presentation, or corresponding low-molecular heparin.

-Platelet count of below 100,000/mm3.

-Significant bleeding disorder at present or within the past 6 months, known haemorrhagic diathesis

-Patients receiving oral anticoagulants, e.g. warfarin sodium (INR>1.3)

-History or evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage

-Severe uncontrolled arterial hypertension

-Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)

-Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy) or other haemorrhagic ophthalmic conditions

-Acute pancreatitis

-Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis

-Ongoing treatment with chemotherapy

-Drugs which may increase the plasma concentration of imatinib - ketokonazol, itrakonazol, erythromycin and claritomycin

-Drugs which may decrease the plasma concentration of Imatinib: Dexametason, phenytoin, karbamazepin, rifampizin, phenobarbital, fosphenytoin, primidon, Hypericum performatum (Johannesört)

-Major surgery or significant trauma in past 10 days (this includes any trauma associated with current acute myocardial infarction), recent trauma to head or cranium

-Pregnancy not excluded if patient is in childbearing potential