Autor: |
Macarena Hernández-Jiménez, Francisco Abad-Santos, Ian Cotgreave, Jaime Gallego, Bernd Jilma, Alan Flores, Tudor G. Jovin, José Vivancos, Carlos A. Molina, Joan Montaner, Joaquín Casariego, Mads Dalsgaard, María Hernández-Pérez, David S. Liebeskind, Erik Cobo, Marc Ribo |
Jazyk: |
angličtina |
Rok vydání: |
2023 |
Předmět: |
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Zdroj: |
Frontiers in Neurology, Vol 14 (2023) |
Druh dokumentu: |
article |
ISSN: |
1664-2295 |
DOI: |
10.3389/fneur.2023.1127585 |
Popis: |
In the reperfusion era, a new paradigm of treating patients with endovascular treatment (EVT) and neuroprotective drugs is emerging as a promising therapeutic option for patients with acute ischemic stroke (AIS). In this context, ApTOLL, a Toll-like receptor 4 (TLR4) antagonist with proven neuroprotective effect in preclinical models of stroke and a very good pharmacokinetic and safety profile in healthy volunteers, is a promising first-in-class aptamer with the potential to address this huge unmet need. This protocol establishes the clinical trial procedures to conduct a Phase Ib/IIa clinical study (APRIL) to assess ApTOLL tolerability, safety, pharmacokinetics, and biological effect in patients with AIS who are eligible for EVT. This will be a multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to evaluate the administration of ApTOLL together with EVT in patients with AIS. The study population will be composed of men and non-pregnant women with confirmed AIS with a |
Databáze: |
Directory of Open Access Journals |
Externí odkaz: |
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