Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
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
1 other identifier
interventional
674
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2018
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2018
CompletedStudy Start
First participant enrolled
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2020
CompletedJune 22, 2020
December 1, 2019
1.9 years
March 13, 2018
June 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
90days
Secondary Outcomes (10)
Proportion of Neurological Improvement
90 days
Scores of Neurological Improvement
24 hours
Long-term Change from Baseline
90 days
Proportion of Long-term Improvement
90 days
Systemic hemorrhage
90days
- +5 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALRecombinant human urokinase (rhPro-UK)
Group B
ACTIVE COMPARATORAlteplase(rt-PA)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Beijing Luhe Hospital,Capital Medical University
Beijing, Beijing Municipality, China
XuanWu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
The First Hospital of Handan
Handan, Hebei, China
Harrison International Peace Hospital
Hengshui, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tangshan Gongren Hospital
Tangshan, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Changsha
Changsha, Hunan, China
First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 100053, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
The Second People'Hospital of Huai'an
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, China
First Hospital of Jilin University
Changchun, Jilin, China
The Neuropsychiatric Hospital of Jilin Province
Siping, Jilin, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
Shenyang Military Region General Hospital
Shenyang, Liaoning, China
The 163th Hospital of the Chinese People's Liberation Army
Shenyang, Liaoning, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
The People's Hospital of Sichuan Province
Chengdu, Sichuan, China
Deyang people's hospital
Deyang, Sichuan, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Luoyang Central Hospital
Luoyang, Zhengzhou, China
Related Publications (1)
Song H, Wang Y, Ma Q, Feng W, Liu R, Lv X, Huang L, Li Y, Yang Y, Geng D, Zhu J, Wei Y, Chen H, Zhu R, Zhai Q, Guo J, Liu B, Zhao S, Wang Y; PROST collaborative group. Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Ischemic Stroke Within 4.5 Hours of Stroke Onset: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2325415. doi: 10.1001/jamanetworkopen.2023.25415.
PMID: 37490291DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2018
First Posted
May 30, 2018
Study Start
May 18, 2018
Primary Completion
April 14, 2020
Study Completion
May 24, 2020
Last Updated
June 22, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share