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
- Conditions
- Acute ischemic strokeMedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-002148-56-FR
- Lead Sponsor
- ACTICOR BIOTECH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
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
(MT)
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
test.
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
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
(MRA)
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.
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