The First Affiliated Hospital of Zhengzhou University
Phase
Phase 3
Started
2026-06-01
Last updated
2026-06-01
Condition(s) studied
Acute Ischemic Stroke
Investigational drug(s) / intervention(s)
rhPro-UKplaceboAspirinPlacebo
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
More The First Affiliated Hospital of Zhengzhou University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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