EUCTR2010-019014-25-SE进行中（未招募）不适用
A PROSPECTIVE, RANDOMISED, OPEN, BLINDED EVALUATION, ASCENDING-DOSE, PILOT TRIAL OF IMATINIB IN ACUTE ISCHAEMIC STROKE (I-STROKE/pilot)
Karolinska University Hospital0 个研究点开始时间: 2010年5月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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
排除标准
- •-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
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