Abstract Number: LPB0051
Meeting: ISTH 2021 Congress
Background: Standard of care (SoC) for acute ischemic stroke (AIS), (intravenous tPA and mechanical thrombectomy) showed great benefit. However, still many patients suffer from an unfavourable outcome, highlighting the importance for developing new reperfusion strategies. Glenzocimab, a novel antibody fragment targeting platelet GPVI, is evaluated to safely improve reperfusion therapy.
Aims: The goal of the ACTIMIS trial is to address the safety of glenzocimab on top of the SoC in AIS patients. The first study milestone was to complete the escalating dose phase Ib and to choose a safe dose to be administered during phase IIa.
Methods: ACTIMIS is an exploratory, multinational, multicenter, randomized, double blind, placebo-controlled, single parallel escalating dose study. Patients eligible to tPA with stroke symptoms onset ≤ 4.5hr and some of them to mechanical thrombectomy were randomly assigned to receive either placebo (n=12) or glenzocimab (6-hour infusion) following a sequential escalating dose scheme, 125mg, 250mg, 500mg and 1000mg (n=12 per dose). The primary endpoint is the occurrence of symptomatic and non-symptomatic intracranial hemorrhages (s- and ns-ICHs), serious adverse events (SAEs), bleeding-related events (BREs) and deaths.
Results: Sixty patients, treated with IV tPA, including 50% with an additional MT, were included. Among the 40 SAEs reported, 17 of them were reported as ICHs (1 symptomatic, 16 non-symptomatic including 15 hemorrhagic transformations). Of the 23 other reported SAEs, none was related to the study drug, the majority of them recovered and 5 had a fatal outcome within 90 days. Among non-ICH bleeding-related events, none was related to study drug. There was no dose-effect for any of the safety related parameters.
Conclusions: Glenzocimab showed a favorable safety profile with a 1.7% s-ICH rate, lower than the reported percentage in tPA RCTs, representing a promising achievement. The highest dose of 1000mg was selected for phase IIa.
To cite this abstract in AMA style:Mazighi M, Peeters A, Richard S, Molina C, Lemmens R, Toni D, Plétan Y, Jandrot-Perrus M, Comenducci A, Avenard G, Lyrer P, Kohrmann M, ACTIMIS Study Group . ACTIMIS Trial: Safety Interim Analysis Data of Glenzocimab, a Novel Antiplatelet Agent on Top of Acute Ischemic Stroke Standard of Care [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1). https://abstracts.isth.org/abstract/actimis-trial-safety-interim-analysis-data-of-glenzocimab-a-novel-antiplatelet-agent-on-top-of-acute-ischemic-stroke-standard-of-care/. Accessed September 24, 2021.
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