Trials / Completed
CompletedNCT03578822
Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Tasly Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant human urokinase | Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min. |
| DRUG | Aspirin | Aspirin 300mg is taken orally at the beginning of thrombolysis. |
| DRUG | rhPro-UK simulation agent | Patients receive rhPro-UK simulation agent 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min. |
| DRUG | Aspirin simulation agent | Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis. |
Timeline
- Start date
- 2018-08-10
- Primary completion
- 2020-02-28
- Completion
- 2020-03-01
- First posted
- 2018-07-06
- Last updated
- 2020-04-28
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03578822. Inclusion in this directory is not an endorsement.