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临床试验/ISRCTN71616222
ISRCTN71616222已完成未知

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 人开始时间: 2013年10月22日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
264
研究概览入排标准研究者记录与标识符相似试验

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •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

排除标准

  • •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
  • •11. Recent history (in the opinion of the investigator) or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm or cerebral neoplasm
  • •12. Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6) or any activated partial thromboplastin (aPTT) time exceeding 1.5-times the normal range or prolonged Thrombin-Time (TT), indicating the potential use of Dabigatran-Etexilate
  • •13. Use of heparin, except for low-dose subcutaneous heparin, within 48 hours prior to randomization
  • •14. Use of glycoprotein IIb-IIIa inhibitors within 72 hours prior to randomization
  • •15. Clinically significant hypoglycemia
  • •16. Uncontrolled hypertension defined by blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least two separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of aggressive treatment is left to the discretion of the investigator
  • •17. Hereditary or acquired hemorrhagic diathesis
  • •18. Gastrointestinal or urinary bleeding within 21 days prior to randomization
  • •19. Major surgery within 14 days prior to randomization which poses a risk in the opinion of the investigator
  • •20. Exposure to a thrombolytic agent within 72 hours prior to randomization

研究者

发起方
Ruprecht-Karls-University Heidelberg (Germany)

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