rhPro-UK in Acute Ischaemic Stroke Within 4.5 Hours of Stroke Onset Trial 2(PROST-2)
Status:
Not yet recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke
within 4ยท5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase)
is the preferred thrombolytic agent for this purpose.
RhPro-UK is a specific plasminogen activator. rhPro-UK only acts on occlusive thrombus and
has little effect on hemostatic thrombus. In addition, rhPro-UK does not form covalent
complexes with protease inhibitors in plasma, so the concentrations of rhpro-UK and protease
inhibitors in the blood do not decrease compared with alteplase. Therefore, rhPro-UK
therapies have a potential advantage of less systemic bleeding in treated subjects. Data from
several previous studies suggest that rhPro-UK is efficacious when used to treat patients
with acute myocardial infarction. On April 2, 2011, rhPro-UK injection was approved by the
National Medical Products Administration to treat acute myocardial infarction. Since then,
rhPro-UK has been widely used to treat myocardial infarction in China.
Since 2016, we carried a phase 2 clinical trial to explore the dosing of rhPro-UK in patients
with acute ischemic stroke, followed by another study with a sample size of 680 patients to
initially validate the efficacy and safety of the proposed dose of 35mg. The results of these
studies suggested that rhPro-UK was effective, and there were no safety concerns. To further
prove the efficacy and safety of rhPro-UK in patients with acute ischemic stroke, we
conducted this phase 3 study (PROST-2).