Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)

Sponsor
Tasly Biopharmaceuticals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03541668
Collaborator
(none)
674
35
2
24.2
19.3
0.8

Study Details

Study Description

Brief Summary

This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
674 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset
Actual Study Start Date :
May 18, 2018
Actual Primary Completion Date :
Apr 14, 2020
Actual Study Completion Date :
May 24, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Recombinant human urokinase (rhPro-UK)

Drug: Recombinant human urokinase
Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.
Other Names:
  • rhPro-UK
  • Active Comparator: Group B

    Alteplase(rt-PA)

    Drug: Alteplase
    Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.
    Other Names:
  • rt-PA
  • Outcome Measures

    Primary Outcome Measures

    1. Functional handicap [90days]

      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.

    Secondary Outcome Measures

    1. Proportion of Neurological Improvement [90 days]

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

    2. Scores of Neurological Improvement [24 hours]

      NIHSS changes from baseline at 24 hours after treatment

    3. Long-term Change from Baseline [90 days]

      NIHSS, mRS and 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.

    4. Proportion of Long-term Improvement [90 days]

      Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment.

    5. Systemic hemorrhage [90days]

      Severe systemic hemorrhage

    6. Symptomatic intracerebral hemorrhage [90days]

      Symptomatic intracerebral hemorrhage (sICH)

    7. Death [7 days and 90 days]

      Death

    8. Recurrence [7 days]

      Recurrence of stroke

    9. Liver function [7 days]

      The incidence of ALT≥3ULN in liver biochemical examination

    10. Renal function [7 days]

      The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Ischemic stroke with symptoms of neurological deficits.

    2. Aged 18 to 80 years(including the critical value).

    3. NIH Stroke Scale(NIHSS)scores of 4 to 25(including the critical value).

    4. Treatment within 4.5 hours after stroke onset.

    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. Informed Consent Form signed by the patients or family (legal representatives) must be provided.

    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 after stroke.

    5. Intracranial tumor, arteriovenous malformation and aneurysm.

    6. Iatrogenic Stroke.

    7. Planned for thrombectomy.

    8. Cardioembolism and atrial fibrillation.

    9. Myocardial infarction history within 3 months.

    10. Severe cerebral trauma or stroke history within 3 months.

    11. Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.

    12. Intracranial hemorrhage or subarachnoid hemorrhage on baseline.

    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 48h and increased APTT is above ULN.

    20. Using of oral anticoagulant drugs and PT >15s or INR >1.7.

    21. High risk of acute hemorrhage include platelet count<10^9/L.

    22. Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.

    23. Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.

    24. Pregnancy, lactating or menstrual women.

    25. The investigator believes that the patient is not suitable for the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Luhe Hospital,Capital Medical University Beijing Beijing China
    2 XuanWu Hospital, Capital Medical University Beijing Beijing China
    3 Liuzhou Worker's Hospital Liuzhou Guangxi China
    4 Cangzhou Central Hospital Cangzhou Hebei China
    5 The First Hospital of Handan Handan Hebei China
    6 Harrison International Peace Hospital Hengshui Hebei China
    7 The First Hospital of Hebei Medical University Shijiazhuang Hebei China
    8 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China
    9 Tangshan Gongren Hospital Tangshan Hebei China
    10 Daqing Oilfield General Hospital Daqing Heilongjiang China
    11 The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China
    12 The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China
    13 The First Hospital of Changsha Changsha Hunan China
    14 First Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia China 100053
    15 Baotou Central Hospital Baotou Inner Mongolia China
    16 Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia China
    17 Inner Mongolia People's Hospital Hohhot Inner Mongolia China
    18 Huai'an First People's Hospital Huai'an Jiangsu China
    19 The Second People'Hospital of Huai'an Huai'an Jiangsu China
    20 Nanjing Drum Tower Hospital Nanjing Jiangsu China
    21 The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China
    22 Xuzhou Central Hospital Xuzhou Jiangsu China
    23 Jiangxi Pingxiang People's Hospital Pingxiang Jiangxi China
    24 First Hospital of Jilin University Changchun Jilin China
    25 The Neuropsychiatric Hospital of Jilin Province Siping Jilin China
    26 Dalian Municipal Central Hospital Dalian Liaoning China
    27 Shenyang Military Region General Hospital Shenyang Liaoning China
    28 The 163th Hospital of the Chinese People's Liberation Army Shenyang Liaoning China
    29 Liaocheng People's Hospital Liaocheng Shandong China
    30 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China
    31 The People's Hospital of Sichuan Province Chengdu Sichuan China
    32 Deyang people's hospital Deyang Sichuan China
    33 Tianjin Huanhu Hospital Tianjin Tianjin China
    34 Taizhou Hospital of Zhejiang Province Taizhou Zhejiang China
    35 Luoyang Central Hospital Luoyang Zhengzhou China

    Sponsors and Collaborators

    • Tasly Biopharmaceuticals Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tasly Biopharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03541668
    Other Study ID Numbers:
    • TASLY-B1440-CTP-Ⅲa
    First Posted:
    May 30, 2018
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2020