Starting soon
Phase 3
Pro-urokinase for Extended-Window Posterior Circulation Stroke
Condition(s) studied
Acute Ischemic Stroke
Investigational drug(s) / intervention(s)
rhPro-UK: rhPro-UK (5 mg/vial), to maximum of 35mg
placebo: Asprin (placebo)
Aspirin: Asprin (300mg)
Placebo: rhPro-UK(placebo)
Study summary
This study aims to evaluate whether, in patients with imaging-confirmed acute ischemic stroke of the posterior circulation presenting within 4.5-24 hours after symptom onset and not scheduled for endovascular thrombectomy, intravenous thrombolysis with recombinant human prourokinase (rhPro-UK), compared with standard medical treatment, can achieve superior 90-day functional outcomes with a higher level of safety.
Eligibility
Inclusion Criteria:
1. Age ≥ 18 years;
2. AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);
3. Imaging criteria:
1. DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;
2. DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;
4. NIHSS score 4-25;
5. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);
6. Signed informed consent from the patient or legally authorized representative.
Exclusion Criteria:
1. Planned endovascular treatment;
2. Contradictory to MRI examination;
3. MRI image not qualified for evaluation;
4. Serious neurological deficits before onset (mRS≥2);
5. Obvious head injuries or strokes within 3 months;
6. Subarachnoid or intracranial hemorrhage;
7. History of intracranial hemorrhage;
8. Intracranial tumor, arteriovenous malformation or aneurysm;
9. Intracranial or spinal cord surgery within 3 months;
10. Active internal hemorrhage;
11. platelet count of \<100000/mm3;
12. Aortic arch dissection;
13. Heparin therapy within 24 hours;
14. Oral warfarin is being taken and INR\>1.6 or APTT abnormal;
15. Oral anticoagulation therapy;
16. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;
17. Blood glucose \< 50 mg/dl (2.7mmol/L);
18. Pregnancy;
19. Neurological deficit after epileptic seizures;
20. Major surgery within 1 month;
21. Gastrointestinal or urinary tract hemorrhage within the previous 30 days;
22. Myocardial infarction within 3 months;
23. Allergy to study drugs;
24. Unlikely to adhere to the trial protocol or follow-up;
25. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;
26. Participation in other interventional clinical trials within the previous 3 months.
Primary outcome measure(s)
- Modified Rankin Scale (mRS) — 90 ± 7 days]
Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 ± 7 days.
Trial sites (1)
| Facility | City | Region | Status |
| Department of Neurology, the First Affiliated Hospital of Zhengzhou University |
Zhengzhou |
Henan |
|
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