Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial
- Conditions
- Acute Ischaemic Stroke
- Interventions
- Drug: rhPro-UK simulation agent
- Registration Number
- NCT03578822
- Lead Sponsor
- Tasly Biopharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- 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.
- 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.
- Puncture in 1 week which can not be oppressed.
- Major surgery or severe trauma within 2 weeks.
- Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
- Heparin treatment within 48 hours (APTT above normal upper limit).
- Taking anticoagulant drugs orally, and PT >15s or INR >1.7.
- High risk of acute hemorrhage include platelet count<10^9/L.
- 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.).
- Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
- Pregnancy, lactating or menstrual women.
- Patients who have difficulty swallowing and are unable to take medications orally.
- Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Recombinant human urokinase Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent Group B rhPro-UK simulation agent rhPro-UK simulation agent and Aspirn Group A Aspirin simulation agent Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent Group B Aspirin rhPro-UK simulation agent and Aspirn
- 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 Systemic hemorrhage 90days Severe systemic hemorrhage
Long-term Change from Baseline of NIHSS 90 days NIHSS changes from baseline on 90 days after treatment.
Long-term Change from Baseline of mRS 90 days mRS changes from baseline on 90 days after treatment.
Symptomatic intracerebral hemorrhage 90days Symptomatic intracerebral hemorrhage (sICH)
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.
Scores of Neurological Improvement 24 hours NIHSS changes from baseline at 24 hours after treatment
Index Long-term Change from Baseline of Barthel Index 90 days 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.
Proportion of Long-term Improvement 90 days Proportion of patients achieving a Barthel Index of 75 to 100 at 90 days after treatment.
Death 7 days and 90 days Death
Recurrence 7 days Recurrence of stroke
Trial Locations
- Locations (19)
XuanWu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Harrison International Peace Hospital
🇨🇳Hengshui, Hebei, China
Tangshan Gongren Hospital
🇨🇳Tangshan, Hebei, China
Inner Mongolia People's Hospital
🇨🇳Hohhot, Inner Mongolia, China
Baotou Central Hospital
🇨🇳Baotou, Inner Mongolia, China
The Second People'Hospital of Huai'an
🇨🇳Huai'an, Jiangsu, China
Huai'an First People's Hospital
🇨🇳Huai'an, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
Meihekou Central Hospital
🇨🇳Meihekou, Jilin, China
Shenyang Military Region General Hospital
🇨🇳Shenyang, Liaoning, China
The First People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
First Affiliated Hospital of Baotou Medical College
🇨🇳Baotou, Inner Mongolia, China
Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Dalian Municipal Central Hospital
🇨🇳Dalian, Liaoning, China
Luoyang Central Hospital
🇨🇳Luoyang, Zhengzhou, China