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Glenzocimab for Ischemic Stroke (ACTISAVE Trial)
ACTISAVE Trial Summary
This trial is a study to see if a new drug is effective and safe. The study will test if the drug works better than a placebo (sugar pill) in people with a certain condition.
ACTISAVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowACTISAVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ACTISAVE Trial Design
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Who is running the clinical trial?
Media Library
- You are currently receiving treatment with a monoclonal antibody.Your score on a specific stroke severity test is 6 or higher before receiving a certain type of treatment.You are in a coma or have a very severe stroke, with a high score on the NIH Stroke Scale.You are younger than 18 years old.You had a stroke within the last 3 months.Your ability to function independently before the stroke was limited.You have a large area of abnormality in the middle cerebral artery on a baseline CT or MRI scan.The presence of a large mass in the brain causing displacement of the midline.You have had a stroke caused by bleeding in the brain.You may need to take two types of medication to prevent blood clots within 24 hours after stopping the glenzocimab or placebo infusion, such as if you have a carotid stenting procedure.You have severe kidney problems with very low creatinine clearance.You have had an allergic reaction to contrast agents in the past.You have had cardiopulmonary resuscitation in the past 10 days.You gave birth less than 10 days ago.You had a seizure when the stroke started, which makes it hard to measure your condition before receiving the medicine.You are expected to live for less than 3 months, except for stroke cases.You recently had a severe stroke, and it has been less than 4.5 hours since it happened.You have received IVT treatment, and may or may not be eligible for mechanical thrombectomy, based on the latest guidelines from ASA and ESO.You are taking blood-thinning medication, except for a low dose of injectable heparin for prevention.
- Group 1: Intravenous glenzocimab (ACT017) 1000 mg
- Group 2: Intravenous Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this a new clinical trial?
"Intravenous glenzocimab (ACT017) 1000 mg is being studied in 1 city across 3 countries. The first study was conducted in 2021 and, since then, 9 more studies have been completed. That initial study was sponsored by Acticor Biotech and it included 1000 patients that went through Phase 2 & 3 of drug approval."
What are the desired results of this research?
"The study's primary outcome, which will be tabulated and compared at the Day 90 mark, is the mRS scale applied to a binary poor outcome. Additionally, researchers will secondary outcomes including the Utility Weighted mRS, cerebral tissue reperfusion, and efficacy of glenzocimab vs placebo."
How many people fit the requirements to join this clinical trial?
"Yes, this trial is still open and actively recruiting patients. According to the information available on clinicaltrials.gov, which was last updated on September 28th, 20202, they are looking for a total of 1000 participants from 1 site."
Is the use of Intravenous glenzocimab (ACT017) 1000 mg in medical trials new or has this been done before?
"Currently, there is one clinical study underway researching the effects of Intravenous glenzocimab (ACT017) 1000 mg. One trial is in its third and final phase with the majority of research taking place in Essen, Texas. However, three medical centres across the country are running these trials."
Are there still positions available for participants in this experiment?
"The clinical trial is still recruiting patients, with updated information on September 28th, 2022. The study was first posted on September 23rd, 2021 and is looking for 1000 participants at 1 site."
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