ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKE

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Adult male or female patients = 18 years (i.e., at least 18 years old
at time of randomization).
2. Having given their own written consent or legal representative
consent or emergency consent, and in any case, in strict accordance with country-specific legal
requirements.
3. Presenting with an acute disabling ischemic stroke either in the
anterior or in posterior circulation, with or without visible occlusion,
with a known time of onset, that is = 4.5 hrs
4. Presenting with a pre-IVT NIHSS = 6
5. In whom IVT is or has been initiated, whether
or not patients are additionally eligible to mechanical thrombectomy
(MT+IVT), according to the recommendation of the last guidelines (ASA and ESO recommendations)
6. Women of childbearing potential (WOCBP) must have a negative
serum/urine pregnancy test at baseline. Women of childbearing
potential, i.e, fertile, are defined as women following menarche and until
becoming post-menopausal unless permanently sterile, i.e, having
undergone hysterectomy, bilateral sal pingectomy and bilateral
oophorectomy.
7. Post-menopausal women defined as not having menses for 12 months
without an alternative medical cause. For WOCBP, a highly effective birth control method should be in place that can achieve a failure rate of less
than 1% per year that should last
for 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 associated with 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 that should last for 4 months after IMP administration include:
- vasectomy,
- use of condom combined with a highly effective birth control method
for their WOCBP partner.
Please note that hormonal contraception is a risk factor for
thromboembolic events and attention should be called to reconsider it
passed the acute stroke phase.
8. Patients affiliated to a health insurance – modality depending on
country legal requirement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 133
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 267

Exclusion Criteria

1. Coma, or NIHSS >25
2. Patients < 18 years
3. Protected adults under guardianship or curatorship
4. Prior ischemic stroke within the past 3 months
5. mRS pre-stroke known to be = 2
6. Large (more than 1/3 of the middle cerebral artery) regions of clear
hypodensity on Baseline Computed Tomography Angiography (CTA) or
Magnetic Resonance Imaging (MRI) or with vascular injection (MRA).
7. Significant mass effect with midline shift
8. Stroke of hemorrhagic origin
9. Patients likely to require dual antiplatelet therapy (DAPT) within the
first 24 hrs after cessation of glenzocimab or placebo infusion for e.g.,
carotid stenting
10. Known renal insufficiency (Grades 4-5 – severe or terminal)
with a
creatinine clearance < 30 mL/Mn using Cockroft formula)
11. Known allergic reaction to contrast agents
12. Patients under anti-coagulant therapy, except preventative doese of
injectable low molecular weight heparin (LMWH).
13. Known ongoing treatment with a mAb.
14. Prior cardiopulmonary resuscitation < 10 days.
15. Childbirth within < 10 days.
16. eizures at stroke onset if it precludes obtaining an accurate
baseline (pre-IVT)NIHSS,
17. Life expectancy (except for stroke) < 3 months.
18. Pregnancy or breastfeeding.
19. Females of childbearing potential not using effective birth control methods.
20. Known current participation in another clinical investigation with experimental drug.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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