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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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
Acute Ischaemic Stroke Drug: Recombinant human urokinase Drug: Alteplase Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : April 14, 2020
Actual Study Completion Date : May 24, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

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 Name: 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 Name: rt-PA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Scores of Neurological Improvement [ Time Frame: 24 hours ]
    NIHSS changes from baseline at 24 hours after treatment

  3. 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.

  4. 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.

  5. Systemic hemorrhage [ Time Frame: 90days ]
    Severe systemic hemorrhage

  6. Symptomatic intracerebral hemorrhage [ Time Frame: 90days ]
    Symptomatic intracerebral hemorrhage (sICH)

  7. Death [ Time Frame: 7 days and 90 days ]
    Death

  8. Recurrence [ Time Frame: 7 days ]
    Recurrence of stroke

  9. Liver function [ Time Frame: 7 days ]
    The incidence of ALT≥3ULN in liver biochemical examination

  10. Renal function [ Time Frame: 7 days ]
    The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541668


Locations
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Sponsors and Collaborators
Tasly Biopharmaceuticals Co., Ltd.
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Responsible Party: Tasly Biopharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03541668    
Other Study ID Numbers: TASLY-B1440-CTP-Ⅲa
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action