What is the mechanism of action of this treatment?

Common treatments for stroke, particularly those focusing on the inhibition of platelet aggregation and thrombus formation, work by preventing the formation of blood clots that can obstruct blood flow to the brain. Medications like Glenzocimab, which is being studied for its efficacy and safety, inhibit platelet aggregation, thereby reducing the risk of clot formation. This is crucial for stroke patients as it helps to restore and maintain adequate blood flow to the brain, minimizing the extent of brain damage and improving recovery outcomes. By targeting the underlying cause of ischemic strokes, these treatments can significantly reduce the risk of recurrent strokes and improve overall prognosis.

What side effects are associated with this type of intervention?

Common treatments for stroke that inhibit platelet aggregation or thrombus formation, such as aspirin, clopidogrel, ticagrelor, and vorapaxar, are associated with several side effects. These include bleeding complications like gastrointestinal bleeding, intracranial hemorrhage, and other major bleeding events. Minor side effects can include bruising, nausea, and headaches. Serious adverse events, though less frequent, may involve cerebrovascular events and hypersensitivity reactions.

What prior FDA approvals exist?

FDA-approved treatments for stroke that focus on inhibiting platelet aggregation or thrombus formation include antiplatelet agents like aspirin and clopidogrel, which are commonly used to prevent recurrent strokes. Additionally, thrombolytic agents such as alteplase (tPA) are approved for acute ischemic stroke to dissolve clots. These treatments aim to reduce the risk of clot formation and improve blood flow, similar to the mechanism of action being studied for glenzocimab in the ACTISAVE trial.

What other types of research exist?

Promising alternatives to Glenzocimab for stroke patients include tirofiban, which has shown efficacy in combination with low-dose rt-PA without increasing the risk of intracerebral hemorrhage. Additionally, ongoing research into novel anticoagulants and antiplatelet agents may provide new options in 2024.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90

Summary

This trial tests if adding glenzocimab to standard stroke care can help patients recover better from an acute ischemic stroke. The study aims to see if this combination improves patient outcomes. Glenzocimab has shown promise in previous studies for its safety and potential benefits in severe cases of acute ischemic stroke when used alongside standard treatments.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Binary Poor Outcome on the mRS defined by a score of 4-6 (versions 0-3)

Secondary study objectives

All cause mortality

Brain

Change biochemistry assessments : Cholesterol at 24 hours as compared to Baseline

+68 more

Other study objectives

Imaging for exploratory endpoints

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glenzocimab

Not yet FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke, particularly those focusing on the inhibition of platelet aggregation and thrombus formation, work by preventing the formation of blood clots that can obstruct blood flow to the brain. Medications like Glenzocimab, which is being studied for its efficacy and safety, inhibit platelet aggregation, thereby reducing the risk of clot formation. This is crucial for stroke patients as it helps to restore and maintain adequate blood flow to the brain, minimizing the extent of brain damage and improving recovery outcomes. By targeting the underlying cause of ischemic strokes, these treatments can significantly reduce the risk of recurrent strokes and improve overall prognosis.

The effect of oral antiplatelet agents on tissue plasminogen activator-mediated thrombolysis in a rabbit model of thromboembolic stroke.