A Phase 3 interventional study of Recombinant Human Prourokinase for Injection (rhPro-UK) and standard medical treatment in Ischemic Stroke, Mild and Thrombosis, sponsored by Beijing Tiantan Hospital. Completed at 89 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Beijing Tiantan Hospital · Phase 3, Interventional, and Treatment
The purpose of this study is to investigate the safety and efficacy of rhPro-UK (35mg) versus standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.
After being informed about the study and potential risks, patients who meet the eligibility requirements will be randomized to recombinant human Prourokinase for injection (rhPro-UK) or standard medical treatment in a 1:1 ratio. Written informed consent will be needed.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 1,446 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
rhPro-UK: 35 mg (5 mg per vial, 7 vials in total) Dissolve 15mg (3 vials) of rhPro-UK in 10ml of saline and intravenous bolus within 3 minutes, and dissolve the remaining 20mg (4 vials) in 90ml of saline and intravenous drip within 30 minutes. (Note: after adding saline, overturn it gently once to twice, do not shake vigorously, so as to avoid foaming of the rhPro-UK solution and reduce the efficacy).
Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)
Standard antiplatelet or anticoagulant treatment at the discretion of local investigators according to the 'Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018'.
Drug: standard medical treatment
15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.
Also known as: Puyouke
Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.
Also known as: Aspirin, clopidogrel, anticoagulant
The modified Rankin Scale score (mRS) ≤ 1 at 90 days
The proportion of the modified Rankin Scale score (mRS) ≤ 1 at 90 days.
Time frame: 90 days
Ordinal distribution of mRS at 90 days
Ordinal distribution of mRS at 90 days
Time frame: 90 days
mRS score ≤ 2 at 90 days
The proportion of mRS score ≤ 2 at 90 days
Time frame: 90 days
Early neurological functional improvement
Clinical response rate at 24 hours defined as an improvement on NIHSS score ≥ 4 points compared with the initial deficit or NIHSS score ≤ 1 point
Time frame: 24 hours
Barthel index of 75-100 points at 90 days
The proportion of Barthel index of 75-100 points at 90 days
Time frame: 90 days
Quality of Life (EQ-5D-5L) at 90 days
The value of Quality of Life (EQ-5D-5L) at 90 days
Time frame: 90 days
Activities of Daily Living (Lawton IADL) at 90 days
The score of Activities of Daily Living (Lawton IADL) at 90 days
Time frame: 90 days
Symptomatic intracranial hemorrhage within 36 hours
The rate of symptomatic intracranial hemorrhage within 36 hours (as defined by ECASS III)
Time frame: 36 hours
All-cause death at 90 days
All-cause mortality at 90 days
Time frame: 90 days
Systematic bleeding at 90 days
The rate of systematic bleeding at 90 days (as defined by GUSTO: moderate and severe bleeding)
Time frame: 90 days
Adverse events (AEs)/ serious adverse events (SAEs) within 90 days
The proportion of AEs/SAEs within 90 days
Time frame: 90 days
Plan to share: No
Ran from Nov 2022 to primary completion in Mar 2024, 16 months.
Of 142 non-industry phase 3 interventional studies under Ischemic Stroke, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's 16 months is below that.
Counting every sponsor, half of 166 studies reached it within 27 months; a quarter within 19 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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