Argatroban anticoagulation in patients with acute ischemic stroke (ARGIS-1): a randomized, placebo-controlled safety study.
Research article published in Stroke (2004)
Abstract
BACKGROUND AND PURPOSE: Direct thrombin inhibitors, including argatroban, represent an anticoagulant class distinct from heparins. We investigated the safety of 2 levels of argatroban anticoagulation in acute ischemic stroke. METHODS: This multicenter, randomized, double-blinded, placebo-controlled study included 171 patients with acute (< or =12 hours from onset) stroke and National Institutes of Health Stroke Scale (NIHSS) scores of 5 to 22. Patients received continuous intravenous argatroban (100 microg/kg bolus) at 3 microg/kg per minute (n=59) or 1 microg/kg per minute (n=58), respectively, adjusted to target activated partial thromboplastin times (aPTTs) 2.25x and 1.75x baseline or placebo (n=54) for 5 days. The primary outcome was symptomatic intracranial hemorrhage (ICH) at 30 days. RESULTS: Baseline characteristics including neurologic deficits (median NIHSS score 9) were comparable between groups. Argatroban at mean doses of 2.7 and 1.2 microg/kg per minute increased aPTTs significantly (P<0.001), with mean aPTTs at or near target values throughout infusion. Symptomatic ICH was not significantly different between groups (high-dose argatroban, 5.1%; low-dose argatroban, 3.4%; placebo, 0%; P> or =0.18), with 3 events during argatroban infusion and 2 events > or =7 days after stopping infusion. No significant between-group differences occurred in asymptomatic ICH (7 events), major systemic hemorrhage (no event), or 90-day mortality (13.4% overall). CONCLUSIONS: In this first North American randomized, double-blinded, placebo-controlled study of direct thrombin inhibition in acute ischemic stroke, argatroban at each dose evaluated significantly prolonged aPTTs without increasing ICH or major bleeding. These results suggest that argatroban provides safe anticoagulation in acute ischemic stroke, warranting future studies powered to evaluate its efficacy and more precisely estimate event rates.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Argatroban anticoagulation in patients with acute ischemic stroke (ARGIS-1): a randomized, placebo-controlled safety study.
Por qué esto importa para la hirudoterapia
Este estudio de seguridad aleatorizado, doble ciego y controlado con placebo evaluó dos niveles de dosis de argatrobán (un inhibidor directo de la trombina) en 171 pacientes con accidente cerebrovascular isquémico agudo (≤12 horas desde el inicio) y puntuaciones NIHSS de 5–22. El argatrobán en ambas dosis prolongó significativamente los tiempos de tromboplastina parcial activada sin aumentar significativamente la hemorragia intracraneal sintomática (5,1% dosis alta, 3,4% dosis baja, 0% placebo; P≥0,18) ni el sangrado sistémico mayor (sin eventos), apoyando la anticoagulación segura en esta población. Si bien el argatrobán pertenece a la misma clase amplia de fármacos (inhibidores directos de la trombina) que la hirudina, es un derivado sintético de molécula pequeña derivado de L-arginina sin conexión con las sanguijuelas ni con el secretoma de la sanguijuela. Este estudio no tiene una relevancia defendible para la hirudoterapia ni para el dominio de ASH.
Citación
Argatroban anticoagulation in patients with acute ischemic stroke (ARGIS-1): a randomized, placebo-controlled safety study.
LaMonte et al. · Stroke, 2004
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Añadido a la biblioteca ASH: May 28, 2026 · Última actualización del sitio: June 18, 2026