Extending the time for Thrombolysis in Emergency Neurological Deficits (International)

Phase 3

• Conditions: Acute ischemic stroke

• Registration Number: JPRN-UMIN000006587
• Lead Sponsor: ational Stroke Research Institute (NSRI)Melbourne Brain Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-24
• Study Completion: 2014-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS) 0-1 at 3 months

Secondary Outcome Measures

Name	Time	Method
Categorical shift in mRS at 3 months. Change in >= 8 NIHSS points or reaching <= 1 NIHSS points on this scale. Death due to any cause. Symptomatic ICH. Reperfusion at 24 hrs post stroke. Recanalisation at 24 hrs post stroke. Infarct growth on DWI within 24 hrs. Recurrent stroke at 3 months.