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

Phase 3

Completed

• Conditions: Acute Ischaemic Stroke
• Interventions: Drug: Recombinant human urokinase; Drug: Alteplase

• Registration Number: NCT03541668
• Lead Sponsor: Tasly Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-05-17
• Study Start: 2018-05-18
• Study First Posted: 2018-05-30
• Status Verified: 2019-12
• Primary Completion: 2020-04-14
• Study Completion: 2020-05-24
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 674

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Recombinant human urokinase	Recombinant human urokinase (rhPro-UK)
Group B	Alteplase	Alteplase(rt-PA)

Primary Outcome Measures

Name	Time	Method
Functional handicap	90days	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.

Secondary Outcome Measures

Name	Time	Method
Renal function	7 days	The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value
Systemic hemorrhage	90days	Severe systemic hemorrhage
Symptomatic intracerebral hemorrhage	90days	Symptomatic intracerebral hemorrhage (sICH)
Recurrence	7 days	Recurrence of stroke
Scores of Neurological Improvement	24 hours	NIHSS changes from baseline at 24 hours after treatment
Proportion of Long-term Improvement	90 days	Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment.
Proportion of Neurological Improvement	90 days	Proportion of patients achieving a NIHSS(national institutes of health stroke scale) ≦1 or reduction of ≥4 NIHSS points at 24 hours after treatment.
Long-term Change from Baseline	90 days	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.
Death	7 days and 90 days	Death
Liver function	7 days	The incidence of ALT≥3ULN in liver biochemical examination

Trial Locations

Locations (35)

XuanWu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Luhe Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, 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

Tangshan Gongren Hospital; 🇨🇳 Tangshan, Hebei, China

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The Fourth Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Inner Mongolia People's Hospital; 🇨🇳 Hohhot, Inner Mongolia, China

The Second People'Hospital of Huai'an; 🇨🇳 Huai'an, Jiangsu, China

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China

Jiangxi Pingxiang People's Hospital; 🇨🇳 Pingxiang, Jiangxi, China

Taizhou Hospital of Zhejiang Province; 🇨🇳 Taizhou, Zhejiang, China

Liuzhou Worker's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Cangzhou Central Hospital; 🇨🇳 Cangzhou, Hebei, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China

The First Hospital of Changsha; 🇨🇳 Changsha, Hunan, China

First Affiliated Hospital of Baotou Medical College; 🇨🇳 Baotou, Inner Mongolia, China

Baotou Central Hospital; 🇨🇳 Baotou, Inner Mongolia, China

Affiliated Hospital of Inner Mongolia Medical University; 🇨🇳 Hohhot, Inner Mongolia, China

Huai'an First People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, 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

Liaocheng People's Hospital; 🇨🇳 Liaocheng, Shandong, China

Shenyang Military Region General Hospital; 🇨🇳 Shenyang, Liaoning, China

The 163th Hospital of the Chinese People's Liberation Army; 🇨🇳 Shenyang, Liaoning, 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, China

Luoyang Central Hospital; 🇨🇳 Luoyang, Zhengzhou, China