JPRN-UMIN000006587已完成3 期
Extending the time for Thrombolysis in Emergency Neurological Deficits (International) - EXTEND (International)
ational Stroke Research Institute (NSRI)Melbourne Brain Centre0 个研究点目标入组 400 人开始时间: 2011年10月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Intracranial haemorrhage identified by CT or MRI. 2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of < 4 at randomization. 3. Pre-stroke mRS score of >= 2. 4. Contra indication to imaging with MR with contrast agents. 5. Infarct core >1/3 MCA territory. 6. Participation in any investigational study in the previous 30 days. 7. Any terminal illness such that patient would not be expected to survive more than 1 year. 8. Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. 9. Pregnant women. 10. Previous stroke within last three months. 11. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage, arterio-venous malformation, aneurysm, or cerebral neoplasm. 12. Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6). 13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range. 14. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) prior to study entry is permitted. 15. Clinically significant hypoglycaemia. 16. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. 17. Hereditary or acquired haemorrhagic diathesis. 18. Gastrointestinal or urinary bleeding within the preceding 21 days. 19. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator. 20. Exposure to a thrombolytic agent within the previous 72 hours.
研究者
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