Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437431
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALICE
Brief Summary:
Until recently acute ischemic stroke AIS patients with a baseline large infarct core have been generally excluded from clinical trials of endovascular therapy EVT A first multicenter randomized trial Rescue Japan Limit trial found a significant benefit of EVT in AIS patients with large infarct core DWI-ASPECTS of 3-5 Another non-randomized multicenter prospective study found a positive association of EVT with 3-month outcome in AIS patients with a baseline CTP ischemic core volume 70mL More recently 2 additional randomized trials were published They both confirmed a strong efficacy of EVT in patients with large infarct core However even with EVT the proportion of good outcome 3-month mRS score of 0-3 remains low in these highly severe AIS patients ranging from 8-30 Almost 75 of EVT-treated patients are still severely disabled or dead at 3 months In experimental studies we and others described the pathophysiological features of the downstream microvascular thrombosis DMT in AIS setting highlighting its immediate occurrence and the pivotal role of platelet activation and aggregation In recent clinical studies it has been shown that even with a complete angiographic recanalization after EVT up to 40 of patients presented no-reflow NR a failure of downstream microvascular reperfusion visible on perfusion imaging performed after EVT Some clinical studies reported the clinical impact of NR after successful EVT We found that DMT participated to the development of neurovascular lesions in AIS with both an early ischemic lesion growth risk evolving towards a delayed hemorrhagic transformation HT and vasogenic edema risks and therefore worse outcome Our results suggested that an antiplatelet therapy infused early in AIS patients could reduce both the ischemic lesion but also the risk of delayed vasogenic edema and HT Platelet glycoprotein VI GPVI is a key receptor for collagen and fibrin and plays a major role in platelet activation platelet recruitment and thrombosis Furthermore inhibition of the GPVI does not impair haemostasis and subjects with a genetic or acquired GPVI deficiency are not prone to excessively bleed
Glenzocimab is a monoclonal antibody directed against the GPVI It has been developed as an immediate antiplatelet agent with minimal bleeding risk for treating AIS The ACTIMIS trial a phase IBIIA clinical study that assessed for the first time the glenzocimab IV infusion in AIS patients found very promising safety data including a significant reduce of symptomatic HT 1 vs 78 and mortality rates 78 vs 187 especially in severe AIS patients Our hypothesis is that IV glenzocimab infusion would improve good functional outcome in large ischemic core AIS patients treated with EVT by reducing the DMT ischemic lesion growth and the HT rate
Glenzocimab is a monoclonal antibody directed against the GPVI It has been developed as an immediate antiplatelet agent with minimal bleeding risk for treating AIS The ACTIMIS trial a phase IBIIA clinical study that assessed for the first time the glenzocimab IV infusion in AIS patients found very promising safety data including a significant reduce of symptomatic HT 1 vs 78 and mortality rates 78 vs 187 especially in severe AIS patients Our hypothesis is that IV glenzocimab infusion would improve good functional outcome in large ischemic core AIS patients treated with EVT by reducing the DMT ischemic lesion growth and the HT rate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None