Glenzocimab for REperfusion in the Setting of Endovascular Therapy for Brain infarctioN: GREEN Study

Last updated: September 26, 2022
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Cerebral Ischemia

Stroke

Occlusions

Treatment

N/A

Clinical Study ID

NCT05559398
APHP 201028 / ACT-CS-004
2021-000889-16
  • Ages > 18
  • All Genders

Study Summary

Emergent reperfusion is the main goal for acute ischemic stroke therapy (AIS). Endovascular therapy (EVT) is recommended within 6 hrs of stroke onset, and up to 24 hrs following perfusion imaging criteria.

Despite the major benefit associated with MT, more than 50% of the patients remain disabled at 3 months. Reperfusion rates after MT are critical to determine functional outcome. However, complete reperfusion is obtained in only 50 % of the patients, due to, at least in part, erratic emboli and/or no-reflow processes. The aim of this study is to evaluate the efficacy of glenzocimab in addition to EVT and compared to EVT plus placebo, whether or not associated with ntravenous thrombolysis (IVT), on functional outcome at day 90.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or older (Age≥18 years)
  2. No significant pre-stroke disability (pre-stroke mRS must be equal to 0 or 1);
  3. Indication of EVT within the time-window of 0 to 24 hrs in participants treated withor without intravenous thrombolysis;
  4. Participants presenting with a target mismatch defined by an initial infarct volume (ischemic core) of less than 70 ml, a ratio of volume of ischemic tissue to initialinfarct volume of 1.8 or more, and an absolute volume of potentially reversibleischemia (penumbra) of 15 ml or more on magnetic resonance imaging (MRI) or, when thisis not possible, on perfusion computed tomography (CTP);
  5. Occlusion of the cervical or intracranial internal carotid artery (ICA) or theproximal middle cerebral artery (MCA - M1 and M2), on magnetic resonance angiography (MRA) or, when this is not possible, on CT angiography (CTA);
  6. Informed consent signed:
  • By the patient
  • Or informed consent signed by a family members/trustworthy person if hiscondition does not allow him to express his consent by written as per L. 1111-6,
  • In a situation urgently and in the absence of family members/trustworthy person,the patient can be enrolled. The consent to participate to the research will berequested as soon as the condition of the patient will allow him to consent.
  1. Post-menopausal women defined as not having menses for 12 months without analternative medical cause. For WOCBP, a highly effective birth control method shouldbe in place that can achieve a failure rate of less than 1% per year that should lastfor at least 2 months after IMP administration. Birth control methods which may be considered as highly effective in WOCBP include:
  • combined (estrogen and progestogen containing) hormonal contraception associatedwith inhibition of ovulation (intravaginal, transdermal),
  • progestogen-only hormonal contraception associated with inhibition of ovulation (injectable, implantable)
  • intrauterine device (IUD),
  • intrauterine hormone-releasing system (IUS),
  • bilateral tubal occlusion,
  • vasectomized partner, Birth control methods which may be considered as highly effective for men and thatshould last for 4 months after IMP administration include:
  • vasectomy,
  • use of condom combined with a highly effective birth control method for theirWOCB partner. Please note that hormonal contraception is a risk factor for thromboembolic events andattention should be called to reconsider it passed the acute stroke phase.
  1. Women of child-bearing potential must have negative results of a plasma pregnancy test (serum betaHCG).
  2. Affiliation to social security or any health insurance

Exclusion

Exclusion Criteria:

  1. Contraindications to EVT;
  2. Contraindication to contrast agents
  3. Pre-existing neurologic and psychiatric disease with mRS ≥ 3;
  4. Unknown symptom's onset;
  5. Patients under or needing immediate DAPT administration;
  6. Patients previously treated by tenecteplase within 24 hrs;
  7. Significant mass effect with midline shift as confirmed on CT/MRI;
  8. Gastrointestinal or urinary tract hemorrhage in previous 21 days;
  9. Patient with intracranial haemorrhage
  10. Platelet count <100 000 mm3;
  11. Pregnant or breastfeeding woman;
  12. Known hypersensitivity to glenzocimab or to any of the excipients;
  13. Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate < 30mL/Min/1.73m2;
  14. Participation in another interventional clinical trial within 30 days prior to theinclusion.
  15. Persons deprived of their liberty by a judicial or administrative decision, personssubject to psychiatric care under sections L.3212-1 et L.3213-1 and persons admittedto a health or social institution for purposes other than research (L.1121-6)
  16. Adults subject to a legal protection measure (L.1121-8)
  17. The patient or his/her family (if the patient is unable to give his/her opinion)expresses an inability to return for protocol visits
  18. patients receiving anticoagulants, as already mentioned in the non-authorizedconcomitant treatments
  19. patients who have already received another humanized fragment of monoclonal antibodywith a suspicion of hypersensitivity

Study Design

Total Participants: 260
Study Start date:
October 10, 2022
Estimated Completion Date:
October 10, 2026