NCT03541668
Completed
Phase 3
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
ConditionsAcute Ischaemic Stroke
Overview
- Phase
- Phase 3
- Intervention
- Recombinant human urokinase
- Conditions
- Acute Ischaemic Stroke
- Sponsor
- Tasly Biopharmaceuticals Co., Ltd.
- Enrollment
- 674
- Locations
- 35
- Primary Endpoint
- Functional handicap
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ischemic stroke with symptoms of neurological deficits.
- •Aged 18 to 80 years（including the critical value）.
- •NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）.
- •Treatment within 4.5 hours after stroke onset.
- •The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
- •CT showed negative or signs of early infarction.
- •Informed Consent Form signed by the patients or family (legal representatives) must be provided.
Exclusion Criteria
- •Patients with premorbid modified Rankin Scale (mRS) score ≥2
- •CT showed multiple infarctions（low density\> 1/3 cerebral hemisphere）.
- •Transient ischemic attack.
- •Epileptic seizure after stroke.
- •Intracranial tumor, arteriovenous malformation and aneurysm.
- •Iatrogenic Stroke.
- •Planned for thrombectomy.
- •Cardioembolism and atrial fibrillation.
- •Myocardial infarction history within 3 months.
- •Severe cerebral trauma or stroke history within 3 months.
Arms & Interventions
Group A
Recombinant human urokinase (rhPro-UK)
Intervention: Recombinant human urokinase
Group B
Alteplase(rt-PA)
Intervention: Alteplase
Outcomes
Primary Outcomes
Functional handicap
Time Frame: 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 Outcomes
- Renal function(7 days)
- Systemic hemorrhage(90days)
- Symptomatic intracerebral hemorrhage(90days)
- Recurrence(7 days)
- Scores of Neurological Improvement(24 hours)
- Proportion of Long-term Improvement(90 days)
- Proportion of Neurological Improvement(90 days)
- Long-term Change from Baseline(90 days)
- Death(7 days and 90 days)
- Liver function(7 days)
Study Sites (35)
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