ArticleNeurology and therapy2026
Effects of Fibrinogen on Tenecteplase Treatment in Acute Ischaemic Stroke After 4.5 Hours of Symptom Onset: A Post Hoc Analysis of the TRACE-III Trial.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05141305 (A Phase 3, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint), which is not on this map. Not yet cited in PubMed.
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A Phase 3, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion With Perfusion Mismatch up to 24 Hours of Symptom Onset
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Abstract
introductionFibrinogen levels may influence the effect of intravenous thrombolysis. We aimed to investigate the efficacy and safety of tenecteplase across different baseline fibrinogen levels in acute ischaemic stroke due to large vessel occlusion (LVO) in the extended time window.
methodsWe performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III (TRACE-III) trial. Patients who presented within 4.5 to 24 h after symptom onset with anterior LVO, salvageable brain tissue, and no access to endovascular thrombectomy were randomised (1:1) to receive either 0.25 mg/kg tenecteplase or standard medical treatment. We categorised patients into groups with non-elevated fibrinogen (≤ 4.0 g/L) and elevated fibrinogen levels (> 4.0 g/L). The primary outcome was the absence of disability, which was defined as a score of 0 to 1 on the modified Rankin scale (mRS) at 90 days. The safety outcomes were symptomatic intracranial haemorrhage (sICH) within 36 h and all-cause mortality within 90 days.
resultsWe included 498 of the 516 patients in the TRACE-III trial who had baseline fibrinogen data. Among them, 426 (85.5%) had non-elevated fibrinogen, and 72 (14.5%) had elevated fibrinogen. Compared with standard medical treatment, tenecteplase significantly increased the proportion of mRS scores of 0-1 at 90 days among patients with non-elevated fibrinogen (35.0% vs. 25.7%; relative rate [RR] 1.55; 95% confidence interval [CI] 1.03-2.37; P = 0.04). No significant difference was observed in those with elevated fibrinogen (16.7% vs. 11.1%; RR 1.60; 95% CI 0.42-6.78; P = 0.50). Safety outcomes were similar between the two treatment groups across fibrinogen categories.
conclusionsAmong patients with LVO presenting within 4.5 to 24 h after stroke onset, those with non-elevated fibrinogen levels may receive greater benefit from tenecteplase in reducing disability risk without increasing the incidence of sICH, compared to those with elevated fibrinogen levels. TRACE-III Trial registration: ClinicalTrials.gov identifier, NCT05141305.
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