Trials / Completed
CompletedNCT04797013
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ
A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,430 (actual)
- Sponsor
- Beijing Tiantan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
Detailed description
To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rt-PA | Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio. |
| DRUG | rhTNK-tPA | Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio. |
Timeline
- Start date
- 2021-06-12
- Primary completion
- 2022-05-29
- Completion
- 2022-07-15
- First posted
- 2021-03-15
- Last updated
- 2023-01-17
Locations
61 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04797013. Inclusion in this directory is not an endorsement.