drugset / Trial / NCT05070260
ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo
RandomizedParallel-groupTriple-blindTreatment
Summary
A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study. The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.
Timeline
- Start
- 2021-09-23
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
Outcome
Missed primary endpoint
paper the incidence of poor outcome (mRS score 4-6 versus 0-3) was 21.6% in the glenzocimab group compared with 15.3% placebo group (odds ratio, 1.51 [95% CI, 0.90-2.54]; P=0.120). PMID 42044230 ↗
paper ACTISAVE failed to confirm a beneficial effect of glenzocimab on mRS in patients with acute ischemic stroke treated by thrombolysis. PMID 42044230 ↗
Publications
- Background Voors-Pette C, Lebozec K, Dogterom P, Jullien L, Billiald P, Ferlan P, Renaud L, Favre-Bulle O, Avenard G, Machacek M, Pletan Y, Jandrot-Perrus M. Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT017, an Antiplatelet GPVI (Glycoprotein VI) Fab. Arterioscler Thromb Vasc Biol. 2019 May;39(5):956-964. doi: 10.1161/ATVBAHA.118.312314.
- Background Renaud L, Lebozec K, Voors-Pette C, Dogterom P, Billiald P, Jandrot Perrus M, Pletan Y, Machacek M. Population Pharmacokinetic/Pharmacodynamic Modeling of Glenzocimab (ACT017) a Glycoprotein VI Inhibitor of Collagen-Induced Platelet Aggregation. J Clin Pharmacol. 2020 Sep;60(9):1198-1208. doi: 10.1002/jcph.1616. Epub 2020 Jun 4.
- Kohrmann M, Berrouschot J, Serena J, Bornstein NM, Iversen HK, Kalladka D, Krastev G, Molina CA, Peeters A, Sanak D, Sibon IP, Della Schiava L, Tembl JI, Masjuan J, Soda H, Richard S, Eichlova Z, Czap AL, Avenard G, Binay S, Bougamra S, Comenducci A, Drumez E, Meilhoc A, Pletan Y, Sari A, Toledano E, Grouin JM, Grotta JC; ACTISAVE Study Group. Glenzocimab Efficacy and Safety Added to Intravenous Thrombolysis With or Without Mechanical Thrombectomy in Patients With Acute Ischemic Stroke-ACTISAVE: A Prospective, Randomized, Double-Blind Study. Stroke. 2026 May;57(5):1116-1125. doi: 10.1161/STROKEAHA.125.052935. Epub 2026 Mar 16.
- Pottecher J, Raffi F, Jandrot-Perrus M, Binay S, Comenducci A, Desort-Henin V, Francois D, Gharakhanian S, Labart M, Meilhoc A, Toledano E, Pletan Y, Avenard G, Sato VH; GARDEN Investigators. Targeting GPVI with glenzocimab in COVID-19 patients: Results from a randomized clinical trial. PLoS One. 2024 Jun 17;19(6):e0302897. doi: 10.1371/journal.pone.0302897. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | glenzocimab | Protein / enzyme biologic | 1000 mg | Intravenous |