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
Overview
- Phase
- Phase 3
- Intervention
- Recombinant human urokinase
- Conditions
- Acute Ischaemic Stroke
- Sponsor
- Tasly Biopharmaceuticals Co., Ltd.
- Enrollment
- 149
- Locations
- 19
- Primary Endpoint
- Functional handicap
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ischemic stroke with symptoms of neurological deficits.
- •Aged 18 to 80 years,male or famale.
- •NIH Stroke Scale（NIHSS）scores of 4 to
- •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.
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 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.
Arms & Interventions
Group A
Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent
Intervention: Recombinant human urokinase
Group A
Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent
Intervention: Aspirin simulation agent
Group B
rhPro-UK simulation agent and Aspirn
Intervention: Aspirin
Group B
rhPro-UK simulation agent and Aspirn
Intervention: rhPro-UK simulation agent
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
- Long-term Change from Baseline of NIHSS(90 days)
- Long-term Change from Baseline of mRS(90 days)
- Symptomatic intracerebral hemorrhage(90days)
- Proportion of Neurological Improvement(90 days)
- Scores of Neurological Improvement(24 hours)
- Index Long-term Change from Baseline of Barthel Index(90 days)
- Proportion of Long-term Improvement(90 days)
- Systemic hemorrhage(90days)
- Death(7 days and 90 days)
- Recurrence(7 days)