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CompletedNCT03578822PROUDUpdated Apr 28, 2020

Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial

A Phase 3 interventional study of Recombinant human urokinase and Aspirin in Acute Ischaemic Stroke, sponsored by Tasly Biopharmaceuticals Co., Ltd.. Completed at 19 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-28.

Sponsored by Tasly Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.

02

Conditions studied

  • Acute Ischaemic Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 149 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Tasly Biopharmaceuticals Co., Ltd. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Ischemic stroke with symptoms of neurological deficits.
  2. Aged 18 to 80 years,male or famale.
  3. NIH Stroke Scale（NIHSS）scores of 4 to 25.
  4. Treatment 4.5 to 6 hours after stroke onset.(Stroke onset time is defined as the last time a patient with no clinical neurological deficit,for patients who wake up with stroke symptoms, consider that stroke occurs when the patient begins to fall asleep).
  5. The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
  6. CT showed negative or signs of early infarction.
  7. Patients and/or their families are willing to participate in this study and agree to sign informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients with premorbid modified Rankin Scale(mRS) score ≥2
  2. CT showed multiple infarctions（low density> 1/3 cerebral hemisphere）.
  3. Transient ischemic attack.
  4. Epileptic seizure when stroke onset.
  5. Intracranial tumor, arteriovenous malformation and aneurysm.
  6. Iatrogenic Stroke.
  7. Thrombectomy is planned.
  8. Cardioembolism and atrial fibrillation.
  9. Myocardial infarction history within 3 months.
  10. Severe cerebral trauma or stroke history within 3 months.
  11. Blood pressure is still out of control after aggressive antihypertensive treatment.Uncontrolled blood pressure is defined as systolic blood pressure≥ 180mmHg or diastolic blood pressure≥100mmHg.
  12. High density lesions (bleeding) and subarachnoid hemorrhage is revealed by emergency CT examination.
  13. Active visceral hemorrhage.
  14. Patients with intracerebral hemorrhage history.
  15. Patients with diabetic retinopathy history.
  16. Puncture in 1 week which can not be oppressed.
  17. Major surgery or severe trauma within 2 weeks.
  18. Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
  19. Heparin treatment within 48 hours (APTT above normal upper limit).
  20. Taking anticoagulant drugs orally, and PT >15s or INR >1.7.
  21. High risk of acute hemorrhage include platelet count\<10\^9/L.
  22. Taking thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination(e.g. APTT, INR, PLT, FIB、TT or appropriate Ⅹ a factor activity test, etc.).
  23. Blood glucose \< 2.7 mmol/L or > 22.2 mmol/L.
  24. Pregnancy, lactating or menstrual women.
  25. Patients who have difficulty swallowing and are unable to take medications orally.
  26. Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    Group A

    Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent

    Drug: Recombinant human urokinase · Drug: Aspirin simulation agent

  • Other
    Group B

    rhPro-UK simulation agent and Aspirn

    Drug: Aspirin · Drug: rhPro-UK simulation agent

Interventions

  • DrugRecombinant human urokinase

    Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.

    Also known as: rhPro-UK

  • DrugAspirin

    Aspirin 300mg is taken orally at the beginning of thrombolysis.

  • DrugrhPro-UK simulation agent

    Patients receive rhPro-UK simulation agent 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.

  • DrugAspirin simulation agent

    Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis.

06

What researchers measure

Primary outcomes

  1. Functional handicap

    Proportion of patients achieving a Modified Rankin Scale(mRS,which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) of 0 to 1 at 90 days after treatment.

    Time frame: 90days

Secondary outcomes

  1. Proportion of Neurological Improvement

    Proportion of patients achieving a NIHSS(national institutes of health stroke scale) ≦1 or reduction of ≥4 NIHSS points at 24 hours after treatment.

    Time frame: 90 days

  2. Scores of Neurological Improvement

    NIHSS changes from baseline at 24 hours after treatment

    Time frame: 24 hours

  3. Index Long-term Change from Baseline of Barthel Index

    Barthel Index(which assesses the ability to perform activities of daily living, on a scale that ranges from 0 to 100) changes from baseline on 90 days after treatment.

    Time frame: 90 days

  4. Long-term Change from Baseline of NIHSS

    NIHSS changes from baseline on 90 days after treatment.

    Time frame: 90 days

  5. Long-term Change from Baseline of mRS

    mRS changes from baseline on 90 days after treatment.

    Time frame: 90 days

  6. Proportion of Long-term Improvement

    Proportion of patients achieving a mRS of 0 to 2 at 90 days after treatment.

    Time frame: 90 days

  7. Proportion of Long-term Improvement

    Proportion of patients achieving a Barthel Index of 75 to 100 at 90 days after treatment.

    Time frame: 90 days

  8. Systemic hemorrhage

    Severe systemic hemorrhage

    Time frame: 90days

  9. Symptomatic intracerebral hemorrhage

    Symptomatic intracerebral hemorrhage (sICH)

    Time frame: 90days

  10. Death

    Death

    Time frame: 7 days and 90 days

  11. Recurrence

    Recurrence of stroke

    Time frame: 7 days

07

Study locations

19 sites
  • XuanWu Hospital, Capital Medical University
    Beijing, Beijing, China
  • Harrison International Peace Hospital
    Hengshui, Hebei, China
  • Tangshan Gongren Hospital
    Tangshan, Hebei, China
  • Baotou Central Hospital
    Baotou, Inner Mongolia, China
  • First Affiliated Hospital of Baotou Medical College
    Baotou, Inner Mongolia, China
  • Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia, China
  • Inner Mongolia People's Hospital
    Hohhot, Inner Mongolia, China
  • Huai'an First People's Hospital
    Huai'an, Jiangsu, China
  • The Second People'Hospital of Huai'an
    Huai'an, Jiangsu, China
  • Zhongda Hospital Southeast University
    Nanjing, Jiangsu, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu, China
  • Xuzhou Central Hospital
    Xuzhou, Jiangsu, China
  • Jiangxi Pingxiang People's Hospital
    Pingxiang, Jiangxi, China
  • First Hospital of Jilin University
    Changchun, Jilin, China
  • Meihekou Central Hospital
    Meihekou, Jilin, China
  • Dalian Municipal Central Hospital
    Dalian, Liaoning, China
  • Shenyang Military Region General Hospital
    Shenyang, Liaoning, China
  • The First People's Hospital of Shenyang
    Shenyang, Liaoning, China
  • Luoyang Central Hospital
    Luoyang, Zhengzhou, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03578822
Lead sponsor
Tasly Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jul 6, 2018
Start date
Aug 10, 2018
Primary completion
Feb 28, 2020
Completion
Mar 1, 2020
Last update
Apr 28, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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