EUCTR2021-002148-56-FR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
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 or legal representative
- •consent or emergency consent in accordance with local 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 = 4
- •5. In whom thrombolysis with tPA is or has been initiated, whether
- •or not patients are additionally eligible to mechanical thrombectomy
- •6. With an effective birth control method (if relevant) that should last
- •for at least 2 months for non-menopausal women, and 4 months for
- •men after IMP administration if applicable according to local
- •regulatory requirement; birth control methods which may be
- •considered as highly effective include:
- •intrauterine device
- •intrauterine hormone-releasing system
- •bilateral tubal occlusion
- •vasectomized partner
- •sexual abstinence
- •7. Women of childbearing potential must have a negative pregnancy
- •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 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •1. Coma, or NIHSS >25
- •2. Patients < 18 years
- •3. Prior ischemic stroke within the past 3 months
- •4. mRS pre-stroke known to be = 2
- •5. Large (more than 1/3 of the middle cerebral artery) regions of clear
- •hypodensity on Baseline Computed Tomography Angiography
- •(CTA) or Magnetic Resonance Imaging with vascular injection
- •6. Significant mass effect with midline shift
- •7. Stroke of hemorrhagic origin
- •8. Patients likely to require dual antiplatelet therapy within the 12
- •hrs after cessation of glenzocimab or placebo infusion for e.g.,
- •carotid stenting
- •9. Known renal insufficiency (Grades 4-5 – severe or terminal)
- •10. Known allergic reaction to contrast agents
- •11. Prior cardiopulmonary resuscitation < 10 days
- •12. Childbirth within < 10 days
- •13. Epileptic seizure at symptom onset
- •14. Life expectancy < 3 months
- •15. Pregnancy or breastfeeding
- •16. Females of childbearing potential not using effective birth
- •control methods
- •17. Life expectancy (apart for stroke) greater than 3 months
- •18. Known current participation in another clinical investigation
- •with experimental drug.
研究者
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