Safety and efficacy of administering the drug Tenecteplase into a cerebral artery after incomplete restoration of blood flow due to occlusions within the brain (TECNO)
Descrizione riassuntiva dello studio
In some patients, after an occlusion of the large cerebral arteries, incomplete restoration of blood flow may occur due to small blood clot fragments. After the removal of these clot fragments, the additional administration of a thrombolytic drug (Tenecteplase) may be beneficial. Developing and testing therapies targeting small residual blood clot fragments after the removal of the large clot has a significant impact on the health future of patients. It is crucial whether they can live without disability after a stroke.
(BASEC)
Intervento studiato
The aim of the study is to find out whether the administration of a thrombolytic drug (Tenecteplase) can dissolve these clot fragments and thus lead to better restoration of blood flow to the brain tissue and further reduction of the severity of the stroke. To pursue this goal, a total of 156 patients will be assigned in a 1:1 ratio either to the additional administration of Tenecteplase or to the current standard treatment (no further therapy). Improvement in blood flow restoration will be evaluated after 25 minutes and 24 hours after randomization. The severity of the stroke will be checked after 24 hours and after 90 days to see if brain damage could be reduced.
(BASEC)
Malattie studiate
The most severe strokes caused by hypoperfusion are due to an occlusion of a large cerebral artery. Currently, the standard treatment for these patients involves the mechanical removal of the blood clot using special instruments introduced through the groin. While this treatment method is beneficial for many patients, the blood clot can only be partially removed in up to 40% of cases, leaving small clot fragments in the small cerebral arteries. This restoration of blood flow to the brain tissue, although improved compared to the initial situation, is incomplete and is associated with a reduced chance of complete recovery. Therefore, therapies that dissolve these small clot fragments are desirable.
(BASEC)
- Informed consent, age ≥ 18 years - Clinical signs indicating a sudden ischemic stroke - Patient had a first large vessel occlusion in the anterior circulation of the brain (defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2) - The patient underwent stroke treatment within the vessels - Randomization no later than < 705 minutes (11h 45min) after symptom onset/last time the patient was healthy (BASEC)
Criteri di esclusione
- Sudden bleeding in the skull - Non-applicability for magnetic resonance imaging (e.g., pacemaker) - Severe bleeding within the last 6 months - Major surgical procedures in the last 2 months - Oral intake of vitamin K antagonists (medication that displaces vitamin K and thus inhibits blood coagulation) with INR > 1.7 - Platelets < 50,000 - Uncontrolled hypertension (defined as SBP > 185 mmHg or DBP > 110 mmHg, which are not treatable) (BASEC)
Luogo dello studio
Basilea, Berna, Ginevra, Lugano, San Gallo, Zurigo
(BASEC)
Sponsor
Inselspital Bern
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Johannes Kaesmacher
+41 31 632 03 64
nctu@clutterinsel.chInselspital Bern Universitätsklinik für Neuroradiologie Freiburgstrasse 3010 Bern
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
28.06.2022
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Safety and Efficacy of intra-arterial Tenecteplase for non-complete reperfusion of intracranial occlusions (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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