Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial

Acute Ischaemic Stroke Clinical Trial

— PROUD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578822
• Other study ID #: TASLY-B1440-CTP-?b
• Status: Completed
• Phase: Phase 3
• Start date: August 10, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Tasly Biopharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 1, 2020
• Est. primary completion date: February 28, 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,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 ? 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.

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 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.
• Aspirin
Aspirin 300mg is taken orally at the beginning of thrombolysis.
• rhPro-UK simulation agent
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
Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis.

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongolia
China	First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	XuanWu Hospital, Capital Medical University	Beijing	Beijing
China	First Hospital of Jilin University	Changchun	Jilin
China	Dalian Municipal Central Hospital	Dalian	Liaoning
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	Luoyang Central Hospital	Luoyang	Zhengzhou
China	Meihekou Central Hospital	Meihekou	Jilin
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shenyang Military Region General Hospital	Shenyang	Liaoning
China	The First People's Hospital of Shenyang	Shenyang	Liaoning
China	Tangshan Gongren Hospital	Tangshan	Hebei
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	Index Long-term Change from Baseline of Barthel Index	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	Long-term Change from Baseline of NIHSS	NIHSS changes from baseline on 90 days after treatment.	90 days
Secondary	Long-term Change from Baseline of mRS	mRS 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 at 90 days after treatment.	90 days
Secondary	Proportion of Long-term Improvement	Proportion of patients achieving 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