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

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ClinicalTrials.gov Identifier: NCT03541668
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Tasly Biopharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE May 18, 2018
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
Functional handicap [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • Proportion of Neurological Improvement [ Time Frame: 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.
  • Scores of Neurological Improvement [ Time Frame: 24 hours ]
    NIHSS changes from baseline at 24 hours after treatment
  • Long-term Change from Baseline [ Time Frame: 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.
  • Proportion of Long-term Improvement [ Time Frame: 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.
  • Systemic hemorrhage [ Time Frame: 90days ]
    Severe systemic hemorrhage
  • Symptomatic intracerebral hemorrhage [ Time Frame: 90days ]
    Symptomatic intracerebral hemorrhage (sICH)
  • Death [ Time Frame: 7 days and 90 days ]
    Death
  • Recurrence [ Time Frame: 7 days ]
    Recurrence of stroke
  • Liver function [ Time Frame: 7 days ]
    The incidence of ALT≥3ULN in liver biochemical examination
  • Renal function [ Time Frame: 7 days ]
    The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • Proportion of Neurological Improvement [ Time Frame: 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.
  • Scores of Neurological Improvement [ Time Frame: 24 hours ]
    NIHSS changes from baseline at 24 hours after treatment
  • Long-term Change from Baseline [ Time Frame: 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.
  • Proportion of Long-term Improvement [ Time Frame: 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.
  • Systemic hemorrhage [ Time Frame: 90days ]
    Severe systemic hemorrhage
  • Symptomatic intracerebral hemorrhage [ Time Frame: 90days ]
    Symptomatic intracerebral hemorrhage (sICH)
  • Death [ Time Frame: 7 days and 90 days ]
    Death
  • Recurrence [ Time Frame: 7 days ]
    Recurrence of stroke
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischaemic Stroke
Intervention  ICMJE
  • 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 Name: rhPro-UK
  • 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 Name: rt-PA
Study Arms  ICMJE
  • Experimental: Group A
    Recombinant human urokinase (rhPro-UK)
    Intervention: Drug: Recombinant human urokinase
  • Active Comparator: Group B
    Alteplase(rt-PA)
    Intervention: Drug: Alteplase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2020)
674
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
700
Actual Study Completion Date  ICMJE May 24, 2020
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03541668
Other Study ID Numbers  ICMJE TASLY-B1440-CTP-Ⅲa
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tasly Biopharmaceuticals Co., Ltd.
Study Sponsor  ICMJE Tasly Biopharmaceuticals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tasly Biopharmaceuticals Co., Ltd.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP