Efficacy and safety study of glenzocimab as add on therapy in AIS
Research type
Research Study
Full title
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
IRAS ID
305622
Contact name
Laurie JULLIEN
Contact email
Sponsor organisation
ACTICOR BIOTECH
Eudract number
2021-002148-56
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 12 days
Research summary
Stroke is one of the leading causes of death worldwide and the most frequent reason for permanent disability. Symptoms are typically a sudden onset of weakness down one side of the body or sudden loss of some neurological function such as sensation, vision, often on one side. “Ischaemic” stroke results from blockage of a blood vessel in the brain. This stroke, accounting for 85% of all stroke cases, is the subject of this clinical trial. The critical goal for patients undergoing an ischaemic stroke is the timely restoration of blood flow to salvage the brain tissue that is not yet affected. The longer the brain is deprived of oxygen and nutrients, the higher is the likelihood of permanent damage to the brain. Patients diagnosed with acute ischaemic stroke will be recruited in the study.
Glenzocimab is an investigational drug administered alongside “alteplase”, the standard clot-dissolving treatment in patients with acute ischaemic stroke and is expected to prevent blood clots from forming inside blood vessels. In this trial, patients who have received the novel drug are compared with those who have received a placebo, which looks like the study drug but which does not include the active ingredient.
The total time taking part in this study will be no longer than 90 days, including the following periods:
• screening and randomisation, when the study doctors will see if the patient is eligible to participate and they will be allocated either to glenzocimab or, either to placebo.
• treatment (administrated as an intravenous infusion) The alteplase infusion will start no later than 4.5 hrs after stroke symptoms onset and glenzocimab or matching placebo will be administered as soon as possible, not later than 1 hour after the end of the alteplase infusion.
• follow-up: including 4 visits at 24hours, 7, 30 and at 90 days.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0288
Date of REC Opinion
4 Feb 2022
REC opinion
Further Information Favourable Opinion