RT Journal Article
SR Electronic
T1 P024 ACTISAVE study: efficacy and safety of glenzocimab on top of thrombolysis and mechanical thrombectomy
JF Journal of NeuroInterventional Surgery
JO J NeuroIntervent Surg
FD BMJ Publishing Group Ltd.
SP A36
OP A36
DO 10.1136/jnis-2024-ESMINT.61
VO 16
IS Suppl 2
A1 Köhrmann, Martin
A1 Toledano, Elie
A1 Plétan, Yannick
A1 Comenducci, Andrea
A1 Meilhoc, Adeline
A1 Binay, Sophie
A1 Avenard, Gilles
A1 Grotta, James
YR 2024
UL http://jnis.bmj.com/content/16/Suppl_2/A36.2.abstract
AB Introduction Glenzocimab is a monoclonal antibody fragment targeting platelet glycoprotein VI, inhibiting platelet activation and aggregation. ACTIMIS study (NCT03803007) described the safety profile of glenzocimab in AIS patients, on top of thrombolysis (IVT) with or without mechanical thrombectomy (MT), and showed a trend in efficacy measured by mRS at day-90 in patients treated by IVT and MT.Aim of Study Glenzocimab was evaluated in ACTISAVE study (NCT05070260) for the treatment of Acute Ischemic Stroke (AIS) on top of standard of care.Methods ACTISAVE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adaptive phase 2/3 study in AIS patients, treated by IVT within 4.5 hours of symptoms onset with or without MT. Patients were randomized in a 1:1 ratio and treated by an IV dose (1000 mg) of glenzocimab or placebo. Patients were also randomized according to the standard of care (SOC) received, IVT alone or IVT with MT. A subgroup analysis for patients treated with both SOC was performed.Results Among 421 patients treated in ACTISAVE study, 159 (38%) of them received the double SOC with a recanalization assessment.Preliminary data indicates that among patients receiving bridging therapy, median age [Q1-Q3] was 73 [65-82] with a gender proportion (F/M) of 51/49%; 78% of patients were aged ≥ 65 years, including 32% ≥ 80 years. Pre-IVT NIHSS median score [Q1-Q3] was 15 [10–20].The optimal recanalization (eTICI 2c-3) was achieved in 107 (67%) patients.Conclusion Unblinded results of ACTISAVE clinical trial will be available by ESMINT 2024 and presented by treatment group.Disclosure of Interest yes JCG is a consultant for Frazer Ltd and a DSMB, advisory board member for Acticor and Prolong Pharma. MK has received speaker’s honoraria and/or compensation for advisory board participation from: Boehringer Ingelheim, Bayer, Daiichi Sankyo, Pfizer, BMS, AstraZeneca, Sanofi, Novartis, Biogen, Acticor. MK is member of the supervisory board of CompuGroup Medical SE & Co. KGaA. AC, AM, ET, SB are employees of Acticor Biotech. GA, SB and YP have management role at Acticor Biotech. AC, AM, ET, GA, SB and YP have stock interest in Acticor Biotech.