Clinical Trials List
2012-05-01 - 2018-12-03
Phase III
Suspended8
Study ended1
Extending the time for Thrombolysis in Emergency Neurological Deficits
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Trial Applicant
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Sponsor
National Stroke Research Institute (NSRI) Melbourne Brain Centre / China Medical University Hospital Clinical Trial Center
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- SHIN-JOE YEH Division of Neurology
- SUNG-CHUN TANG Division of Neurology
- LI-KAI TSAI Division of Neurology
- 李崇維 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Suspended
Co-Principal Investigator
- 葉旭霖 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Suspended
The Actual Total Number of Participants Enrolled
0 Suspended
The Actual Total Number of Participants Enrolled
0 Suspended
The Actual Total Number of Participants Enrolled
0 Suspended
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Suspended
Co-Principal Investigator
- 許致善 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Suspended
Co-Principal Investigator
- Hui-Chun Huang Division of Neurology
- Chung-Hsiang Liu Division of Neurology
- Jui-Cheng Chen Division of Neurology
- Yu-Wan Yang Division of Neurology
- Wei-Shih Huang Division of Neurology
- Kuan-Fei Chen Division of Neurology
- Ching-Hua Lu Lu Division of Neurology
- Yi-Ting Hsu Division of Neurology
- Kang-Hsu Lin Division of Neurology
- Fu-Yu Lin Division of Neurology
- 曾鈞宏 Division of Neurology
- Ming-Kuei Lu Division of Neurology
- Yuh-Cherng Guo Division of Neurology
- Yi-Chien Yang Division of Neurology
The Actual Total Number of Participants Enrolled
12 Study ended
Co-Principal Investigator
- Han-Wei Huang Division of Neurology
- Pi-Shan Sung Division of Neurology
- 謝函潔 Division of Neurology
- 蘇慧貞 Division of Neurology
- 莊明宗 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Suspended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Modified Rankin Scale (mRS) 0 – 1 at 90 days
Secondary
Categorical shift in mRS at 90 days
Change in ≥ 8 NIHSS points or reaching ≤ 1 on this scale
Death due to any cause
Symptomatic ICH
Reperfusion at 24 hrs post stroke
Recanalisation at 24 hrs post stroke
Infarct growth within 24 hrs
Recurrent stroke at 3 months
Inclution Criteria
2. Patient, family member or legally responsible person
depending on local ethics requirements has given informed
consent
3. Patient‟s age is ≥ 18 years (or as per local requirements)
4. Treatment onset can commence after 4.5 hours and up to
and including 9 hours after stroke onset according to
registered product information, or greater than 3 hours up to
and including 9 hours according to locally accepted
guidelines.
5. Patients who wake with stroke may be included if
neurological and other exclusion criteria are satisfied. These
„wake up‟ strokes are defined as having no symptoms at
sleep onset, but stroke symptoms on waking. The time of
stroke onset is to be taken as the mid-point between sleep
onset (or last known to be normal) and time of waking. The
maximum time window for randomisation is then 9 hours
from the mid-point as described
6. Significant neurological deficit (eg NIHSS score of ≥ 4 - 26)
with clinical signs of hemispheric infarction.
Imaging inclusion criteria
7. Penumbral mismatch – A “hypo-perfusion to core” volume
ratio of greater than 1.2, and an absolute difference greater
than 10 ml (using a MR or CT Tmax > 6 second delay)
between perfusion lesion and MR-DWI or CT-CBF core
lesion.
8. An infarct core lesion of less than or equal to 70 ml using
MR-DWI or CT-CBF
Exclusion Criteria
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 (indicating previous disability)
4. Contra indication to imaging with contrast agents
5. Infarct core >1/3 MCA territory qualitatively
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 (this applies to patients with severe
microangiopathy such as haemolytic uremic syndrome or
thrombotic thrombocytopenic purpura). The judgment is left
to the discretion of the Investigator.
9. Pregnant women (clinically evident)
10. Previous stroke within last three months
11. Recent past history or clinical presentation of ICH,
subarachnoid haemorrhage (SAH), arterio-venous (AV)
malformation, aneurysm, or cerebral neoplasm. At the
discretion of each Investigator.
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 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. The definition of “aggressive treatment” is left
to the discretion of the responsible Investigator.
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
The Estimated Number of Participants
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Taiwan
100 participants
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Global
400 participants
