Trials / Completed
CompletedNCT03541668
Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 674 (actual)
- Sponsor
- Tasly Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Alteplase | 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. |
Timeline
- Start date
- 2018-05-18
- Primary completion
- 2020-04-14
- Completion
- 2020-05-24
- First posted
- 2018-05-30
- Last updated
- 2020-06-22
Locations
35 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03541668. Inclusion in this directory is not an endorsement.