drugset / Trial / NCT05507645
ProUrokinase for Mild Ischemic Cerebrovascular Events (PUMICE)
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to investigate the safety and efficacy of rhPro-UK (35mg) versus standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.
Timeline
- Start
- 2022-11-15
- Primary completion
- 2024-03-26
- Completion
- 2024-06-17
Outcome
Missed primary endpoint
paper The primary outcome occurred in 639 patients (88.5%) in the prourokinase group and 658 (91.0%) in the standard care group (relative risk, 0.97; 95% CI, 0.94-1.01; 2-sided P = .12). PMID 39836393 ↗
paper prourokinase was not superior to standard care to improve the functional outcomes PMID 39836393 ↗
Publications
- Xiong Y, Meng X, Jin A, Campbell BCV, Xu A, Dong Q, Xu Y, Pan Y, Jiang Y, Niu S, Li Z, Zhuang X, Guo N, Yuan Z, Kong Z, Zong L, Duan C, Cao Z, Wang L, Hao M, Wu S, Feng X, Li H, Wu N, Li Z, Zhao X, Wang Y; PUMICE Investigators. Prourokinase vs Standard Care for Patients With Mild Ischemic Stroke: The PUMICE Randomized Clinical Trial. JAMA Neurol. 2025 Mar 1;82(3):258-266. doi: 10.1001/jamaneurol.2024.4688.
- Xiong Y, Hao M, Pan Y, Duan C, Feng X, Li H, Wu N, Wang L, Meng X, Zhao X, Wang Y; PUMICE investigators*. Rationale and design of ProUrokinase in Mild IsChemic strokE (PUMICE): a multicentre, prospective, randomised, open-label, blinded-endpoint controlled trial. Stroke Vasc Neurol. 2024 Dec 30;9(6):715-722. doi: 10.1136/svn-2023-002673.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhPro-UK | Protein / enzyme biologic | 35 mg | Intravenous |
| Comparator | Aspirin | Small molecule | — | — |
| Comparator | Clopidogrel | Small molecule | — | — |