PROST-2
Trial question
Is recombinant human prourokinase noninferior to alteplase in patients with AIS?
Study design
Multi-center
Open label
RCT
Population
1552 patients.
Inclusion criteria: adult patients with AIS who were ineligible for refused endovascular thrombectomy.
Key exclusion criteria: prestroke mRS score ≥ 2; ICH; severe cerebral trauma or stroke in the past 3 months; intracranial tumor or giant intracranial aneurysm; intracranial or intraspinal surgery in the past 3 months; gastrointestinal or urinary bleeding in the past 3 weeks.
Interventions
N=775 recombinant human prourokinase (intravenous infusion of 15 mg bolus followed by 20 mg infusion within 30 minutes).
N=777 alteplase (intravenous infusion of 0.9 mg/kg, maximum dose 90 mg).
Primary outcome
Modified Rankin Scale score of 0 or 1 at 90 days
72%
68.7%
72.0 %
54.0 %
36.0 %
18.0 %
0.0 %
Recombinant human
prourokinase
Alteplase
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in mRS score of 0 or 1 at 90 days (72% vs. 68.7%; RR 1.04, 95% CI 0.98 to 1.1).
Secondary outcomes
No significant difference in all-cause mortality at day 7 (0.6% vs. 1.7%; ARD -1, 95% CI -2.3 to 0.1).
Significant decrease in major bleeding at day 7 (0.5% vs. 2.1%; ARD -1.5, 95% CI -2.8 to -0.4).
Safety outcomes
Significant difference in symptomatic ICH within 36 hours (0.3% vs. 1.3%).
Conclusion
In adult patients with AIS who were ineligible for refused endovascular thrombectomy, recombinant human prourokinase was noninferior to alteplase with respect to mRS score of 0 or 1 at 90 days.
Reference
Shuya Li, Hong-Qiu Gu, Baoyu Feng et al. Safety and efficacy of intravenous recombinant human prourokinase for acute ischaemic stroke within 4·5 h after stroke onset (PROST-2): a phase 3, open-label, non-inferiority, randomised controlled trial. Lancet Neurol. 2025 Jan;24(1):33-41.
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