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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study. The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.

Key facts

Study ID

NCT05070260

Run by

Acticor Biotech

People needed

438

Starts

2021-09-23

Expected to finish

2024-04-30

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female patients ≥ 18 years (i.e., at least 18 years old at time of randomization)
• Having given their own written consent, or legal representative consent, and in any case, in strict accordance with country-specific legal requirements,
• 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
• Presenting with a pre-IVT NIHSS ≥ 6
• 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),
• 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
• 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.
• Patients affiliated to a health insurance - modality depending on country legal requirement

You may not qualify if…

• Coma, or NIHSS >25,
• Patients < 18 years,
• Protected adults under guardianship or curatorship,
• Prior ischemic stroke within the past 3 months,
• mRS pre-stroke known to be ≥ 2,
• 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),
• Significant mass effect with midline shift,
• Stroke of hemorrhagic origin,
• 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,
• Known renal insufficiency (Grades 4-5 - severe or terminal with a creatinine clearance < 30 mL/min using Cockroft formula),
• Known allergic reaction to contrast agents,
• Patients under anti-coagulant therapy, except preventative doses of injectable low molecular weight heparin (LMWH),
• Known ongoing treatment with a mAb,
• Prior cardiopulmonary resuscitation < 10 days,
• Childbirth within < 10 days,
• Seizures at stroke onset if it precludes obtaining an accurate baseline (pre-IVT) NIHSS,
• Life expectancy (except for stroke) < 3 months,
• Pregnancy or breastfeeding,
• Females of childbearing potential not using effective birth control methods,
• Known current participation in another clinical investigation with experimental drug.

Where it is running

• Black Medical center — Bradenton, Florida, United States
• Nova Clinical Research — Bradenton, Florida, United States
• Northside hospital — St. Petersburg, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Washington university — St Louis, Missouri, United States
• Miami Valley hospital — Dayton, Ohio, United States
• Chattanooga center for neurological research — Chattanooga, Tennessee, United States
• Houston Methodist hospital — Houston, Texas, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• University Clinic Essen — Essen, Germany

Full record on ClinicalTrials.gov

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