NCT03578822CompletedPhase 3
A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5-6 Hours After Stroke Onset
Tasly Biopharmaceuticals Co., Ltd.19 sites in 1 country149 target enrollmentStarted: August 10, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 149
- Locations
- 19
- Primary Endpoint
- Functional handicap
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
- •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.
Arms & Interventions
Group A
Experimental
Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent
Intervention: Recombinant human urokinase (Drug)
Group A
Experimental
Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent
Intervention: Aspirin simulation agent (Drug)
Group B
Other
rhPro-UK simulation agent and Aspirn
Intervention: Aspirin (Drug)
Group B
Other
rhPro-UK simulation agent and Aspirn
Intervention: rhPro-UK simulation agent (Drug)
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)
Investigators
Study Sites (19)
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