TASTE
Trial question
Is tenecteplase noninferior to alteplase in patients with AIS within 4.5 hours of onset?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 680
680 patients (260 female, 420 male).
Inclusion criteria: adult patients with AIS within 4.5 hours of onset or last known well who were selected by perfusion imaging.
Key exclusion criteria: ICH; pre-stroke mRS score ≥ 2; previous stroke within last 3 months; clinically significant hypoglycemia; uncontrolled hypertension; known hypersensitivity to alteplase/tenecteplase.
Interventions
N=339 tenecteplase (at a dose of 0.25 mg/kg).
N=341 alteplase (at a dose of 0.90 mg/kg).
Primary outcome
Modified Rankin Scale score of 0-1 at 3 months, per-protocol analysis
59%
56%
59.0 %
44.3 %
29.5 %
14.8 %
0.0 %
Tenecteplase
Alteplase
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in mRS score of 0-1 at 3 months, per-protocol analysis (59% vs. 56%; SRD 0.05, 95% CI -0.02 to 0.12).
Secondary outcomes
Significant decrease in mRS score of 0-1 at 3 months, intention-to-treat analysis (57% vs. 55%; SRD 0.03, 95% CI -0.03 to 0.1).
Significant decrease in symptomatic ICH (3% vs. 2%; RD 0.01, 95% CI -0.01 to 0.03).
Significant decrease in death at day 90 (7% vs. 4%; SRD 0.02, 95% CI -0.02 to 0.05).
Conclusion
In adult patients with AIS within 4.5 hours of onset or last known well who were selected by perfusion imaging, tenecteplase was noninferior to alteplase with respect to mRS score of 0-1 at 3 months, per-protocol analysis.
Reference
Mark W Parsons, Vignan Yogendrakumar, Leonid Churilov et al. Tenecteplase versus alteplase for thrombolysis in patients selected by use of perfusion imaging within 4·5 h of onset of ischaemic stroke (TASTE): a multicentre, randomised, controlled, phase 3 non-inferiority trial. Lancet Neurol. 2024 Aug;23(8):775-786.
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