European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ? a double-blind, placebo-controlled randomized study

Ruprecht-Karls-University Heidelberg (Germany)0 个研究点目标入组 264 人2013年10月22日

概览

注册库

who.int

开始日期

2013年10月22日

结束日期

2016年8月31日

最后更新

6年前

研究类型

Interventional

性别

All

发起方

Ruprecht-Karls-University Heidelberg (Germany)

•1\. Patients presenting with acute ischemic stroke
•2\. Patient or legally acceptable representative has given written informed consent. An independent witness may sign the consent form if the patient is able to give verbal consent but unable to sign
•3\. Patients, male and female, aged 18 years or over
•4\. Treatment onset within 4\.5 and 9 hours after stroke onset or patients waking up with stroke symptoms and unclear time window
•5\. National Institutes of Health Stroke Scale (NIHSS) score of 4 to 26 with clinical signs of hemispheric infarction
•6\. Penumbral mismatch imaging via local assessment following predefined criteria using standardized criteria including a perfusion volume (PWI) to infarct core (DWI) ratio of \= 1\.2, and a minimum perfusion lesion volume of 20 ml

•1\. Intracranial hemorrhage (ICH) identified by CT or MRI
•2\. Rapidly improving symptoms, particularly if, in the opinion of the investigator, the improvement is likely to result in the patient having an NIHSS score of \<4 at randomization
•3\. Pre\-stroke modified Rankin Scale (mRS) score of \>1 (indicating previous disability)
•4\. Contraindication to imaging with MRI
•5\. Infarct core \>1/3 MCA territory qualitatively or \>100 ml quantitatively (determined by DWI lesion on MRI)
•6\. Participation in any investigational study in the previous 30 days
•7\. A life expectancy of less than 3 months
•8\. Any condition that, in the opinion of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as hemolytic uremic syndrome or thrombotic thrombocytopenic purpura)
•9\. Pregnant (clinically evident) or breastfeeding women
•10\. Previous stroke within the three months prior to randomization