Clinical trial NCT03578822: Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial
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 4.5-6 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: 2018-07-06
Enrollment: 149
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,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.


Eligibility criteria: Inclusion Criteria:

1. Ischemic stroke with symptoms of neurological deficits.
2. Aged 18 to 80 years,male or famale.
3. NIH Stroke Scale（NIHSS）scores of 4 to 25.
4. 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).
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. Patients and/or their families are willing to participate in this study and agree to sign informed consent.

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 when stroke onset.
5. Intracranial tumor, arteriovenous malformation and aneurysm.
6. Iatrogenic Stroke.
7. Thrombectomy is planned.
8. Cardioembolism and atrial fibrillation.
9. Myocardial infarction history within 3 months.
10. Severe cerebral trauma or stroke history within 3 months.
11. 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.
12. High density lesions (bleeding) and subarachnoid hemorrhage is revealed by emergency CT examination.
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 48 hours (APTT above normal upper limit).
20. Taking anticoagulant drugs orally, and PT \>15s or INR \>1.7.
21. High risk of acute hemorrhage include platelet count\<10\^9/L.
22. Taking thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination(e.g. APTT, INR, PLT, FIB、TT or appropriate Ⅹ a factor activity test, etc.).
23. Blood glucose \< 2.7 mmol/L or \> 22.2 mmol/L.
24. Pregnancy, lactating or menstrual women.
25. Patients who have difficulty swallowing and are unable to take medications orally.
26. Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions.

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: Index Long-term Change from Baseline of Barthel Index
timeFrame: 90 days
measure: Long-term Change from Baseline of NIHSS
timeFrame: 90 days
measure: Long-term Change from Baseline of mRS
timeFrame: 90 days
measure: Proportion of Long-term Improvement
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
Other outcomes:
Locations:
city: Beijing
country: China
facility: XuanWu Hospital, Capital Medical University
state: Beijing
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Baotou
country: China
facility: First Affiliated Hospital of Baotou Medical College
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: Zhongda Hospital Southeast University
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: Meihekou
country: China
facility: Meihekou Central Hospital
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 First People's Hospital of Shenyang
state: Liaoning
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Zhengzhou
Study officials:
References: