EUCTR2021-002148-56-CZ进行中（未招募）1 期
A RANDOMIZED, DOUBLE BLIND, MULTICENTER, MULTINATIONAL, PLACEBO CONTROLLED, PARALLEL GROUP, SINGLE DOSE, 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 - ACTISAVE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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 = 4
- •5. In whom thrombolysis with rt-PA is or has been initiated, whether
- •or not patients are additionally eligible to mechanical thrombectomy
- •(MT + alteplase).
- •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.
- •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 333
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 667
排除标准
- •1. Coma, or NIHSS >25
- •2. Patients < 18 years
- •3. Patients unable to consent
- •4. Protected adults under guardianship or curatorship
- •5. Prior ischemic stroke within the past 3 months
- •6. mRS pre-stroke known to be = 2
- •7. Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on Baseline Computed Tomography or Angiography (CTA) or Magnetic Resonance Imaging (MRI) or with vascular injection (MRA).
- •8. Significant mass effect with midline shift
- •9. Stroke of hemorrhagic origin
- •10. Patients likely to require dual antiplatelet therapy (DART) within the first 24 hrs after cessation of glenzocimab or placebo infusion for e.g., carotid stenting
- •11. Known renal insufficiency (Grades 4-5 – severe or terminal)
- •12. Known allergic reaction to contrast agents
- •13. Patients under anti-coagulant therapy, except preventative dose of
- •injectable low molecular weight heparin (LMWH).
- •14.Known ongoing treatment with a mAb.
- •15. Prior cardiopulmonary resuscitation < 10 days.
- •16. Childbirth within < 10 days.
- •17. Seizures at stroke onset if it precludes obtaining an accurate
- •baseline (pre-IVT)NIHSS,
- •Epileptic seizure at symptom onset.
- •18. Life expectancy (except for stroke) < 3 months.
- •19. Pregnancy or breastfeeding.
- •20. Females of childbearing potential not using effective birth control methods.
- •21. Known current participation in another clinical investigation with experimental drug.
研究者
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