ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo

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, 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 recommandations),
• •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 salpingectomy 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