Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial
PROUD
A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5-6 Hours After Stroke Onset
1 other identifier
interventional
149
1 country
19
Brief Summary
This is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2018
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedStudy Start
First participant enrolled
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedApril 28, 2020
April 1, 2020
1.6 years
June 20, 2018
April 26, 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 (11)
Proportion of Neurological Improvement
90 days
Scores of Neurological Improvement
24 hours
Index Long-term Change from Baseline of Barthel Index
90 days
Long-term Change from Baseline of NIHSS
90 days
Long-term Change from Baseline of mRS
90 days
- +6 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALRecombinant human urokinase(rhPro-UK) and Aspirin simulation agent
Group B
OTHERrhPro-UK simulation agent and Aspirn
Interventions
Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.
Patients receive rhPro-UK simulation agent 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.
Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis.
Eligibility Criteria
You may qualify if:
- Ischemic stroke with symptoms of neurological deficits.
- Aged 18 to 80 years,male or famale.
- NIH Stroke Scale（NIHSS）scores of 4 to 25.
- Treatment 4.5 to 6 hours after stroke onset.(Stroke onset time is defined as the last time a patient with no clinical neurological deficit,for patients who wake up with stroke symptoms, consider that stroke occurs when the patient begins to fall asleep).
- The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
- CT showed negative or signs of early infarction.
- Patients and/or their families are willing to participate in this study and agree to sign informed consent.
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 when stroke onset.
- Intracranial tumor, arteriovenous malformation and aneurysm.
- Iatrogenic Stroke.
- Thrombectomy is planned.
- Cardioembolism and atrial fibrillation.
- Myocardial infarction history within 3 months.
- Severe cerebral trauma or stroke history within 3 months.
- Blood pressure is still out of control after aggressive antihypertensive treatment.Uncontrolled blood pressure is defined as systolic blood pressure≥ 180mmHg or diastolic blood pressure≥100mmHg.
- High density lesions (bleeding) and subarachnoid hemorrhage is revealed by emergency CT examination.
- Active visceral hemorrhage.
- Patients with intracerebral hemorrhage history.
- Patients with diabetic retinopathy history.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
XuanWu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Harrison International Peace Hospital
Hengshui, Hebei, China
Tangshan Gongren Hospital
Tangshan, Hebei, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
First Affiliated Hospital of Baotou Medical College
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
Zhongda Hospital Southeast University
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
Meihekou Central Hospital
Meihekou, Jilin, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
Shenyang Military Region General Hospital
Shenyang, Liaoning, China
The First People's Hospital of Shenyang
Shenyang, Liaoning, China
Luoyang Central Hospital
Luoyang, Zhengzhou, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 6, 2018
Study Start
August 10, 2018
Primary Completion
February 28, 2020
Study Completion
March 1, 2020
Last Updated
April 28, 2020
Record last verified: 2020-04