TRACE III
Trial question
What is the role of tenecteplase in patients with AIS due to large vessel occlusion?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 516
516 patients (166 female, 350 male).
Inclusion criteria: patients with AIS due to large vessel occlusion of the middle cerebral artery or internal carotid artery within 4.5-24 hours from last known to be well.
Key exclusion criteria: planned endovascular thrombectomy; guideline-based contraindications to thrombolytic agents; persistent BP elevation; active internal bleeding or at high risk of bleeding.
Interventions
N=264 tenecteplase (at a dose of 0.25 mg/kg, maximum dose of 25 mg).
N=252 standard medical treatment (antiplatelet therapy at the discretion of the investigators).
Primary outcome
Modified Rankin Scale score ≤ 1 at day 90
33%
24.2%
33.0 %
24.8 %
16.5 %
8.3 %
0.0 %
Tenecteplase
Standard medical
treatment
Significant
increase ▲
NNT = 11
Significant increase in mRS score ≤ 1 at day 90 (33% vs. 24.2%; RR 1.37, 95% CI 1.04 to 1.81).
Secondary outcomes
Significant increase in functional independence at day 90 (43.6% vs. 33.3%; RR 1.31, 95% CI 1.05 to 1.63).
Significant increase in major neurologic improvement at 72 hours (16% vs. 6%; RR 2.66, 95% CI 1.51 to 4.69).
Significant increase in reperfusion at 24 hours (20.1% vs. 11.8%; RR 1.7, 95% CI 1.1 to 2.64).
Safety outcomes
No significant differences in death within 90 days, adverse and severe adverse events.
Conclusion
In patients with AIS due to large vessel occlusion of the middle cerebral artery or internal carotid artery within 4.5-24 hours from last known to be well, tenecteplase was superior to standard medical treatment with respect to mRS score ≤ 1 at day 90.
Reference
Yunyun Xiong, Bruce C V Campbell, Lee H Schwamm et al. Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy. N Engl J Med. 2024 Jul 18;391(3):203-212.
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