Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)

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.

Timeline

Start

2018-05-18

Primary completion

2020-04-14

Completion

2020-05-24

Publications

• Li S, Gu HQ, Feng B, Dong Q, Fan D, Xu Y, Zhu S, Wang Y. RhPro-UK in acute ischemic stroke within 4.5 h of stroke onset trial-2 (the PROST-2 study): Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial. Int J Stroke. 2024 Dec;19(10):1182-1187. doi: 10.1177/17474930241265654. Epub 2024 Aug 3.
• Song H, Wang Y, Ma Q, Feng W, Liu R, Lv X, Huang L, Li Y, Yang Y, Geng D, Zhu J, Wei Y, Chen H, Zhu R, Zhai Q, Guo J, Liu B, Zhao S, Wang Y; PROST collaborative group. Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Ischemic Stroke Within 4.5 Hours of Stroke Onset: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2325415. doi: 10.1001/jamanetworkopen.2023.25415.

Drugs

Indications