Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03578822 | Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial | PHASE3 | COMPLETED | 149 | — | — | Aug 10, 2018 | Mar 1, 2020 | Apr 28, 2020 | 19 | China |
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.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent |
| Group B | OTHER | rhPro-UK simulation agent and Aspirn |
| Name | Type | Description |
|---|---|---|
| Recombinant human urokinase | DRUG | 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. |
| Aspirin | DRUG | Aspirin 300mg is taken orally at the beginning of thrombolysis. |
| rhPro-UK simulation agent | DRUG | 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. |
| Aspirin simulation agent | DRUG | Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis. |
Inclusion Criteria: 1. Ischemic stroke with symptoms of neurological deficits. 2. Aged 18 to 80 years,male or famale. 3. NIH Stroke Scale（NIHSS）scores of 4 to 25. 4. Treatment 4.5 to 6 hours after stroke onset.(Stroke onset time is defined as the last time a patient with no clinical neurological de...