DUMAS
Trial question
What is the role of dual thrombolytic therapy with mutant prourokinase and small bolus alteplase in patients with ischemic stroke?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 238
238 patients (91 female, 147 male).
Inclusion criteria: adult patients with ischemic stroke.
Key exclusion criteria: eligibility for endovascular thrombectomy; prestroke disability interfering with assessment of functional outcome; pregnancy; contraindication to MRI.
Interventions
N=121 mutant prourokinase (bolus of 5 mg intravenous alteplase and 40 mg intravenous infusion of mutant prourokinase).
N=117 alteplase alone (standard treatment with 0.9 mg/kg of intravenous alteplase alone).
Primary outcome
Any intracranial hemorrhage on neuroimaging at 24 hours
13.2%
13.7%
13.7 %
10.3 %
6.8 %
3.4 %
0.0 %
Mutant
prourokinase
Alteplase
alone
No significant
difference ↔
No significant difference in any ICH on neuroimaging at 24 hours (13.2% vs. 13.7%; OR 0.98, 95% CI 0.46 to 2.12).
Secondary outcomes
No significant difference in improvement in NIHSS score at 24 hours (63.6% vs. 70.9%; OR 0.68, 95% CI 0.39 to 1.2).
No significant difference in mean ordinal mRS score at day 30 (2 points vs. 2 points; OR 1.16, 95% CI 0.74 to 1.84).
Borderline significant decrease in mean infarct volume at 24 hours (5.1 mL vs. 7 mL; AD -1.9 mL, 95% CI -3.8 to 0).
Safety outcomes
No significant differences in death at day 30, serious adverse events.
Conclusion
In adult patients with ischemic stroke, mutant prourokinase was not superior to alteplase alone with respect to any ICH on neuroimaging at 24 hours.
Reference
Nadinda A M van der Ende, Bob Roozenbeek, Lucas E M Smagge et al. Safety and Efficacy of Dual Thrombolytic Therapy With Mutant Prourokinase and Small Bolus Alteplase for Ischemic Stroke. JAMA Neurol. 2023 Jul 1;80(7):714-722.
Open reference URL