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

Acute Ischaemic Stroke Clinical 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 Hours After Stroke Onset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541668
• Other study ID #: TASLY-B1440-CTP-?a
• Status: Completed
• Phase: Phase 3
• Start date: May 18, 2018
• Est. completion date: May 24, 2020

Study information

• Verified date: December 2019
• Source: Tasly Biopharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: May 24, 2020
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischaemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Drug:
• Recombinant human urokinase
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.
• Alteplase
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.

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongolia
China	First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	Beijing Luhe Hospital,Capital Medical University	Beijing	Beijing
China	XuanWu Hospital, Capital Medical University	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	First Hospital of Jilin University	Changchun	Jilin
China	The First Hospital of Changsha	Changsha	Hunan
China	The People's Hospital of Sichuan Province	Chengdu	Sichuan
China	Dalian Municipal Central Hospital	Dalian	Liaoning
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Deyang people's hospital	Deyang	Sichuan
China	The First Hospital of Handan	Handan	Hebei
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Harrison International Peace Hospital	Hengshui	Hebei
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	Liaocheng People's Hospital	Liaocheng	Shandong
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	Luoyang Central Hospital	Luoyang	Zhengzhou
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shenyang Military Region General Hospital	Shenyang	Liaoning
China	The 163th Hospital of the Chinese People's Liberation Army	Shenyang	Liaoning
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Neuropsychiatric Hospital of Jilin Province	Siping	Jilin
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tangshan Gongren Hospital	Tangshan	Hebei
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	90 days
Secondary	Scores of Neurological Improvement	NIHSS changes from baseline at 24 hours after treatment	24 hours
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	Systemic hemorrhage	Severe systemic hemorrhage	90days
Secondary	Symptomatic intracerebral hemorrhage	Symptomatic intracerebral hemorrhage (sICH)	90days
Secondary	Death	Death	7 days and 90 days
Secondary	Recurrence	Recurrence of stroke	7 days
Secondary	Liver function	The incidence of ALT=3ULN in liver biochemical examination	7 days
Secondary	Renal function	The incidence of Scr rising to 3 times or = 4mg/dl more than the base value	7 days