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Glenzocimab for Ischemic Stroke (ACTISAVE Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Acticor Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Presenting with a pre-IVT NIHSS ≥ 6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with acute ischemic stroke, who can consent and have health insurance. Women must not be pregnant or breastfeeding and use effective birth control. Participants should have a moderate to severe stroke but not be in a coma or have had a recent stroke or certain other conditions.Check my eligibility
What is being tested?
The ACTISAVE study tests glenzocimab (1000 mg IV) as an add-on to standard care for ischemic stroke against placebo. It's randomized, double-blind, and includes patients from multiple centers internationally who receive one dose of the drug.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to intravenous therapy, immune responses due to monoclonal antibodies like glenzocimab, and complications associated with underlying health conditions.

ACTISAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You recently had a severe stroke, and it has been less than 4.5 hours since it happened.
Select...
Your score on a specific stroke severity test is 6 or higher before receiving a certain type of treatment.
Select...
You have received IVT treatment, and may or may not be eligible for mechanical thrombectomy, based on the latest guidelines from ASA and ESO.

ACTISAVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Binary Poor Outcome on the mRS defined by a score of 4-6 (versions 0-3)
Secondary outcome measures
All cause mortality
Brain
Change biochemistry assessments : Cholesterol at 24 hours as compared to Baseline
+68 more
Other outcome measures
Imaging for exploratory endpoints

ACTISAVE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intravenous glenzocimab (ACT017) 1000 mgExperimental Treatment1 Intervention
Intravenous glenzocimab (ACT017) 1000 mg to be added to thrombolysis +/- mechanical thrombectomy
Group II: Intravenous PlaceboPlacebo Group1 Intervention
Intravenous Placebo to be added to thrombolysis +/- mechanical thrombectomy

Find a Location

Who is running the clinical trial?

Acticor BiotechLead Sponsor
2 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Stroke
160 Patients Enrolled for Stroke
Andrea Comenducci, MDStudy DirectorActicor Biotech
1 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Stroke
160 Patients Enrolled for Stroke

Media Library

Intravenous glenzocimab (ACT017) 1000 mg Clinical Trial Eligibility Overview. Trial Name: NCT05070260 — Phase 2 & 3
Stroke Research Study Groups: Intravenous glenzocimab (ACT017) 1000 mg, Intravenous Placebo
Stroke Clinical Trial 2023: Intravenous glenzocimab (ACT017) 1000 mg Highlights & Side Effects. Trial Name: NCT05070260 — Phase 2 & 3
Intravenous glenzocimab (ACT017) 1000 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05070260 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~125 spots leftby Mar 2025