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2023-509615-92-00CompletedPhase 2

Glenzocimab in Anterior stroke with Large Ischemic Core eligible for Endovascular therapy

Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 May 2024

Next steps

Brief summary (registry, in English)

To assess, in AIS patients with baseline large ischemic core eligible for EVT, the efficacy of intravenous infusion of glenzocimab versus placebo on the proportion of good functional outcome at 3 months.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
304 (actual)
First submitted
9 Feb 2024
Start date
1 May 2024
Lead sponsor
Hopital Fondation Adolphe De Rothschild
Diseases
Stroke
EU CT number
2023-509615-92-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 304
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in another interventional clinical investigational drug or medical device trial within 30 days prior to the inclusion
  • Patients known to have already received other humanized fragment of monoclonal antibody (risk of anaphylaxis)
  • Patients known to be under ongoing immunosuppressive therapy
  • Gastrointestinal or urinary tract haemorrhage in previous 21 days

Other illness

  • Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L3212-1 and L3123-1 and persons admitted to a health or social institution for purposes other than research (L1121-6).
  • Significant pre-stroke disability (mRS>2)
  • Patients known to be under ongoing anti-cancer treatment (radiotherapy, chemotherapy, immunotherapy)
  • Patient with intracranial haemorrhage
  • 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

Lab values

  • 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
  • Patients under or needing immediate dual anti-platelet therapy (DAPT) within the first 24 hours after the cessation of glenzocimab or placebo infusion
  • Platelet count <100 000 mm3

Other

  • Possible tandem occlusion on the baseline imaging requiring an eventual stenting
  • Adults subject to a legal protection measure (L1121-8)
  • Significant mass effect with midline shift as confirmed on CT/MRI
  • Pregnant or breastfeeding woman

Who the study is looking for

  • 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
  • All women in age of procreating must have a negative serum/urine pregnancy test at baseline
  • Affiliation to social security or any health insurance
  • Informed consent signed : By the patient; Or informed consent signed by a family member/ trustworthy person if his condition does not allow him to express his consent by written (L1111-6); In a situation urgently and in absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (14)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre hospitalier Universitaire de BordeauxBordeauxFranceCompleted
Hospices Civils de LyonBronFranceCompleted
Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9FranceCompleted
University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1FranceCompleted
Centre Hospitalier Universitaire De LilleLille CedexFranceCompleted
CHRU de NancyNancyFranceCompleted
Hopital Fondation Adolphe de RothschildParisFranceCompleted
Assistance Publique Hopitaux De ParisParis Cedex 10FranceCompleted
Hopital Universitaire Pitie SalpetriereParis Cedex 13FranceCompleted
Centre Hospitalier Universitaire de NantesSaint-HerblainFranceCompleted
Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex 2FranceCompleted
Hospital FochSuresnesFranceCompleted
Centre Hospitalier Universitaire de ToulouseToulouseFranceCompleted
Centre Hospitalier Régional Universitaire de ToursToursFranceCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.