Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy

Launched by FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial, called the ACTIMIS trial, is studying a new treatment called glenzocimab for patients who have suffered an acute ischemic stroke (AIS) due to a blockage in a major blood vessel in the brain. The goal is to see if giving glenzocimab, an antiplatelet medication, right after the stroke can improve outcomes for patients who have a large area of brain damage and are undergoing a procedure to restore blood flow. Previous studies have shown that even with this procedure, many patients do not recover well. Researchers believe that glenzocimab could help reduce further brain damage and improve recovery.

To be eligible for this trial, participants must be adults over 18 years old who have had a stroke due to a specific type of blockage and who are candidates for a treatment called endovascular therapy within 24 hours of their stroke. Some key factors that would exclude someone from participating include having severe disability before the stroke, certain types of bleeding, or being pregnant. Participants in this trial can expect to receive either the glenzocimab treatment or a placebo (a substance with no active medication) while being closely monitored for any side effects and changes in their condition over time. This study is important as it could lead to better treatment options for patients with severe strokes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 years old
• • Acute ischemic stroke due to an isolated proximal anterior large vessel occlusion (M1 and M2 segment of the middle cerebral artery, terminal internal carotid artery (TICA))
• • Indication of EVT within the time window of 0 to 24 hours in participants treated with or without intravenous thrombolysis.
• • Presenting with a baseline infarct core volume assessed on the MRI (DWI sequence) or CT scan with an ASPECTS\<6
• • Woman \<49 years old must have a negative serum/urine pregnancy test at baseline
• Exclusion Criteria:
• • Possible tandem occlusion on the baseline imaging, potentially requiring stenting
• • Significant pre-stroke disability (mRS\>2)
• • Patients under or needing immediate dual anti-platelet therapy (DAPT) within the first 24 hours after the cessation of glenzocimab or placebo infusion
• • Significant mass effect with midline shift as confirmed on CT/MRI
• • Gastrointestinal or urinary tract haemorrhage in previous 21 days
• • Patient with intracranial haemorrhage
• • Platelet count \<100 000 mm3
• • Known hypersensitivity to glenzocimab or to any of the excipients
• • Known hypersensitivity to the gadolinium used for the brain MRI perfusion, or one of its excipients
• • Known Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate \< 30mL/Min/1.73m2
• * Patients receiving anticoagulants within the last 24 hours and:
• • For heparin, an elevated aPTT -greater than upper limit of normal for laboratory
• • For vitamin K antagonists (ex: warfarin), an INR \>1.7;
• • For direct thrombin inhibitors or direct factor Xa inhibitors, a plasmatic dosage of the drug greater than upper limit of normal for laboratory
• • Pregnant or breastfeeding woman
• • Participation in another interventional clinical investigational drug or medical device trial within 30 days prior to the inclusion.