search
Back to results

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

Primary Purpose

Acute Ischaemic Stroke

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant human urokinase
Alteplase
Sponsored by
Tasly Biopharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischaemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Luhe Hospital,Capital Medical University
  • XuanWu Hospital, Capital Medical University
  • Liuzhou Worker's Hospital
  • Cangzhou Central Hospital
  • The First Hospital of Handan
  • Harrison International Peace Hospital
  • The First Hospital of Hebei Medical University
  • The Second Hospital of Hebei Medical University
  • Tangshan Gongren Hospital
  • Daqing Oilfield General Hospital
  • The First Affiliated Hospital of Harbin Medical University
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The First Hospital of Changsha
  • First Affiliated Hospital of Baotou Medical College
  • Baotou Central Hospital
  • Affiliated Hospital of Inner Mongolia Medical University
  • Inner Mongolia People's Hospital
  • Huai'an First People's Hospital
  • The Second People'Hospital of Huai'an
  • Nanjing Drum Tower Hospital
  • The Affiliated Hospital of Xuzhou Medical University
  • Xuzhou Central Hospital
  • Jiangxi Pingxiang People's Hospital
  • First Hospital of Jilin University
  • The Neuropsychiatric Hospital of Jilin Province
  • Dalian Municipal Central Hospital
  • Shenyang Military Region General Hospital
  • The 163th Hospital of the Chinese People's Liberation Army
  • Liaocheng People's Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The People's Hospital of Sichuan Province
  • Deyang people's hospital
  • Tianjin Huanhu Hospital
  • Taizhou Hospital of Zhejiang Province
  • Luoyang Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Recombinant human urokinase (rhPro-UK)

Alteplase(rt-PA)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Scores of Neurological Improvement
NIHSS changes from baseline at 24 hours after treatment
Long-term Change from Baseline
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
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
Severe systemic hemorrhage
Symptomatic intracerebral hemorrhage
Symptomatic intracerebral hemorrhage (sICH)
Death
Death
Recurrence
Recurrence of stroke
Liver function
The incidence of ALT≥3ULN in liver biochemical examination
Renal function
The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value

Full Information

First Posted
March 13, 2018
Last Updated
June 18, 2020
Sponsor
Tasly Biopharmaceuticals Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03541668
Brief Title
Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
May 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Biopharmaceuticals Co., Ltd.

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischaemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
674 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Recombinant human urokinase (rhPro-UK)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Alteplase(rt-PA)
Intervention Type
Drug
Intervention Name(s)
Recombinant human urokinase
Other Intervention Name(s)
rhPro-UK
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Alteplase
Other Intervention Name(s)
rt-PA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional handicap
Description
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 Outcome Measure Information:
Title
Proportion of Neurological Improvement
Description
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
Title
Scores of Neurological Improvement
Description
NIHSS changes from baseline at 24 hours after treatment
Time Frame
24 hours
Title
Long-term Change from Baseline
Description
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.
Time Frame
90 days
Title
Proportion of Long-term Improvement
Description
Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment.
Time Frame
90 days
Title
Systemic hemorrhage
Description
Severe systemic hemorrhage
Time Frame
90days
Title
Symptomatic intracerebral hemorrhage
Description
Symptomatic intracerebral hemorrhage (sICH)
Time Frame
90days
Title
Death
Description
Death
Time Frame
7 days and 90 days
Title
Recurrence
Description
Recurrence of stroke
Time Frame
7 days
Title
Liver function
Description
The incidence of ALT≥3ULN in liver biochemical examination
Time Frame
7 days
Title
Renal function
Description
The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic stroke with symptoms of neurological deficits. Aged 18 to 80 years（including the critical value）. NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）. Treatment within 4.5 hours after stroke onset. The symptoms of stroke last at least 30 minutes without significant improvement before treatment. CT showed negative or signs of early infarction. Informed Consent Form signed by the patients or family (legal representatives) must be provided. Exclusion Criteria: Patients with premorbid modified Rankin Scale (mRS) score ≥2 CT showed multiple infarctions（low density> 1/3 cerebral hemisphere）. Transient ischemic attack. Epileptic seizure after stroke. Intracranial tumor, arteriovenous malformation and aneurysm. Iatrogenic Stroke. Planned for thrombectomy. Cardioembolism and atrial fibrillation. Myocardial infarction history within 3 months. Severe cerebral trauma or stroke history within 3 months. Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment. Intracranial hemorrhage or subarachnoid hemorrhage on baseline. Active visceral hemorrhage. Patients with intracerebral hemorrhage history. Patients with diabetic retinopathy history. Puncture in 1 week which can not be oppressed. Major surgery or severe trauma within 2 weeks. Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days. Heparin treatment within 48h and increased APTT is above ULN. Using of oral anticoagulant drugs and PT >15s or INR >1.7. High risk of acute hemorrhage include platelet count<10^9/L. Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination. Blood glucose < 2.7 mmol/L or > 22.2 mmol/L. Pregnancy, lactating or menstrual women. The investigator believes that the patient is not suitable for the study.
Facility Information:
Facility Name
Beijing Luhe Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
XuanWu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
The First Hospital of Handan
City
Handan
State/Province
Hebei
Country
China
Facility Name
Harrison International Peace Hospital
City
Hengshui
State/Province
Hebei
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Tangshan Gongren Hospital
City
Tangshan
State/Province
Hebei
Country
China
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
The First Hospital of Changsha
City
Changsha
State/Province
Hunan
Country
China
Facility Name
First Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
100053
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
Inner Mongolia People's Hospital
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
Huai'an First People's Hospital
City
Huai'an
State/Province
Jiangsu
Country
China
Facility Name
The Second People'Hospital of Huai'an
City
Huai'an
State/Province
Jiangsu
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
Country
China
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The Neuropsychiatric Hospital of Jilin Province
City
Siping
State/Province
Jilin
Country
China
Facility Name
Dalian Municipal Central Hospital
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Shenyang Military Region General Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The 163th Hospital of the Chinese People's Liberation Army
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The People's Hospital of Sichuan Province
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Deyang people's hospital
City
Deyang
State/Province
Sichuan
Country
China
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
Country
China
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Zhengzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs