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Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
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Tenecteplase versus alteplase for large vessel occlusion recanalization (T-FLAVOR): Trial protocol
Hiroyuki Kawano1, Teruyuki Hirano1, Manabu Inoue2
1Department of Stroke and Cerebrovascular Medicine, Kyorin University, Tokyo, Japan.
European Stroke Journal
|March 18, 2022
Summary
Tenecteplase may improve recanalization rates in Japanese stroke patients undergoing mechanical thrombectomy compared to alteplase. The T-FLAVOR trial will determine its efficacy and safety in this population.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Pharmacology
Background:
- Tenecteplase offers improved fibrin specificity and half-life over alteplase.
- Limited data exists on tenecteplase use in Japanese stroke patients.
Purpose of the Study:
- To evaluate tenecteplase's superiority over alteplase in achieving recanalization before mechanical thrombectomy.
- To assess the safety and efficacy of tenecteplase in Japanese acute ischemic stroke patients.
Main Methods:
- The T-FLAVOR trial is a phase II, randomized, open-label, superiority study.
- 220 patients with large vessel occlusion stroke will be randomized to receive either alteplase (0.6mg/kg) or tenecteplase (0.25mg/kg) before mechanical thrombectomy.
- Primary outcomes include angiographic reperfusion and symptomatic intracranial hemorrhage.
Main Results:
- The study is ongoing; results are not yet available.
- Safety confirmation phase data on symptomatic intracranial hemorrhage is being collected.
- Efficacy will be measured by substantial angiographic reperfusion and absence of retrievable thrombus.
Conclusions:
- Findings from the T-FLAVOR trial may guide the clinical use of tenecteplase in Japan.
- This study could establish tenecteplase as a routine treatment option for stroke patients undergoing mechanical thrombectomy.
