ORIGINAL
Trial question
Is tenecteplase noninferior to alteplase in patients with AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 1465
1465 patients (446 female, 1019 male).
Inclusion criteria: patients with AIS within 4.5 hours of symptom onset.
Key exclusion criteria: ICH or symptoms suggestive of subarachnoid hemorrhage; acute bleeding diathesis; bacterial endocarditis or pericarditis; acute pancreatitis; significant trauma or major surgery; severe uncontrolled arterial hypertension.
Interventions
N=732 tenecteplase (intravenous dose of 0.25 mg/kg administered as a bolus over 5-10 seconds).
N=733 alteplase (intravenous dose of 0.9 mg/kg administered as an initial bolus then as an infusion over 1 hour).
Primary outcome
Modified Rankin Scale score of 0 or 1 at day 90
72.7%
70.3%
72.7 %
54.5 %
36.4 %
18.2 %
0.0 %
Tenecteplase
Alteplase
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in mRS score of 0 or 1 at day 90 (72.7% vs. 70.3%; RR 1.03, 95% CI 0.97 to 1.09).
Secondary outcomes
No significant difference in symptomatic intracerebral hemorrhage (1.2% vs. 1.2%; RR 1.01, 95% CI 0.37 to 2.7).
No significant difference in death at day 90 (4.6% vs. 5.8%; RR 0.8, 95% CI 0.51 to 1.23).
Safety outcomes
No significant difference in adverse events and serious adverse events.
Conclusion
In patients with AIS within 4.5 hours of symptom onset, tenecteplase was noninferior to alteplase with respect to mRS score of 0 or 1 at day 90.
Reference
Xia Meng, Shuya Li, Hongguo Dai et al. Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke: The ORIGINAL Randomized Clinical Trial. JAMA. 2024 Nov 5;332(17):1437-1445.
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