Clinical trial NCT03541668: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Ischaemic Stroke
Lead sponsor: Tasly Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Functional handicap
timeFrame: 90days
Secondary outcomes:
measure: Proportion of Neurological Improvement
timeFrame: 90 days
measure: Scores of Neurological Improvement
timeFrame: 24 hours
measure: Long-term Change from Baseline
timeFrame: 90 days
measure: Proportion of Long-term Improvement
timeFrame: 90 days
measure: Systemic hemorrhage
timeFrame: 90days
measure: Symptomatic intracerebral hemorrhage
timeFrame: 90days
measure: Death
timeFrame: 7 days and 90 days
measure: Recurrence
timeFrame: 7 days
measure: Liver function
timeFrame: 7 days
measure: Renal function
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: XuanWu Hospital, Capital Medical University
state: Beijing
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Handan
country: China
facility: The First Hospital of Handan
state: Hebei
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Baotou
country: China
facility: First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Huai'an
country: China
facility: The Second People'Hospital of Huai'an
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Siping
country: China
facility: The Neuropsychiatric Hospital of Jilin Province
state: Jilin
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Military Region General Hospital
state: Liaoning
city: Shenyang
country: China
facility: The 163th Hospital of the Chinese People's Liberation Army
state: Liaoning
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: The People's Hospital of Sichuan Province
state: Sichuan
city: Deyang
country: China
facility: Deyang people's hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Zhengzhou
Study officials:
References: