Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
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|ClinicalTrials.gov Identifier: NCT03541668|
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischaemic Stroke||Drug: Recombinant human urokinase Drug: Alteplase||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||674 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 18, 2018|
|Actual Primary Completion Date :||April 14, 2020|
|Actual Study Completion Date :||May 24, 2020|
Experimental: Group A
Recombinant human urokinase (rhPro-UK)
Drug: Recombinant human urokinase
Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.
Other Name: rhPro-UK
Active Comparator: Group B
Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.
Other Name: rt-PA
- 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.
- Proportion of Neurological Improvement [ Time Frame: 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 [ Time Frame: 24 hours ]NIHSS changes from baseline at 24 hours after treatment
- Long-term Change from Baseline [ Time Frame: 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.
- Proportion of Long-term Improvement [ Time Frame: 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.
- Systemic hemorrhage [ Time Frame: 90days ]Severe systemic hemorrhage
- Symptomatic intracerebral hemorrhage [ Time Frame: 90days ]Symptomatic intracerebral hemorrhage (sICH)
- Death [ Time Frame: 7 days and 90 days ]Death
- Recurrence [ Time Frame: 7 days ]Recurrence of stroke
- Liver function [ Time Frame: 7 days ]The incidence of ALT≥3ULN in liver biochemical examination
- Renal function [ Time Frame: 7 days ]The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541668