A randomized controlled trial evaluating intravenous urokinase for patients with acute minor stroke revealed no significant benefit in achieving excellent functional outcomes at 90 days, according to recent findings.
In a study published by BMC Medicine, the TRUST trial, conducted across 25 hospitals in China, enrolled 999 patients with minor stroke symptoms and NIH Stroke Scale scores ≤5 within 6 hours of onset. The trial was a multicenter, open-label, blinded-endpoint study conducted between October 2020 and February 2023.
At 90 days, 84.9% of patients in the urokinase group achieved a modified Rankin scale score of 0–1, compared to 85.7% in the control group receiving guideline-directed best medical therapy. The adjusted risk ratio (RR) was 1.00 (95% CI, 0.96–1.05; p=0.87), demonstrating no significant difference between groups.
Safety outcomes, including symptomatic intracranial hemorrhage within 36 hours, were rare and not statistically significant. Three cases of sICH (0.6%) occurred in the urokinase group, compared to one case (0.2%) in the control group (RR 1.83, 95% CI, 0.16–20.27; p=0.62).
The TRUST trial enrolled a median patient age of 64 years, with 36.9% women. Participants were randomized to receive either urokinase (1,000,000 U intravenously) or guideline-based best medical treatment. Crossover rates were high at 23.8%, but analyses adjusted for this, supporting the robustness of the findings.
Subgroup analyses suggested variability in treatment effects based on factors such as age, diabetes status, and prior antithrombotic use. However, these findings were exploratory and require further investigation.
"For patients with acute minor stroke treated within 6 h of symptom onset, UK intravenous thrombolysis treatment was not found to be beneficial in terms of excellent functional outcome at 90 days, whereas it was safe,” the authors concluded. They noted that the trial’s lack of ethnic diversity limits generalizability, warranting further research in varied populations.
While urokinase remains a potential thrombolytic agent, its role in acute minor stroke care remains uncertain. Future studies could explore specific subgroups or alternative endpoints where urokinase might demonstrate clinical utility.
No competing or conflicting interest was declared in the study.
