Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

NCT ID: NCT05630586

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2027-12-31

Brief Summary

Can Semaglutide help reduce the damage caused by a stroke? ASSET trial is a national, multicenter, clinical trial, investigating the safety and efficacy of Semaglutide in non-diabetic patients with acute ischemic stroke.

Stroke is a worldwide leading cause of long-term disability and death. In the most common type of stroke (ischemic stroke), a blood clot obstructs an artery in the brain, and thereby prevents oxygenated blood from reaching an area of the brain. Brain cells are particularly vulnerable to the lack of oxygen. In the areas most severely affected by a stroke, brain cells die after 5 minutes. As more time pass, the affected area expands, and more brain cells perish. Today, efficient treatments aiming at reestablishing the flow of blood by either breaking down the blood clot (thrombolysis) or removing the clot (thrombektomi) are used. However, a significant amount of patients undergoing succesful treamtent, still suffer permanent disability following an ischemic stroke.

Semaglutide mimics a naturally occurring hormone (glucagon-like peptide-1) and is currently used to treat diabetes and obesity. However, semaglutide has also been shown to possess neuroprotective abilities in recent animal studies, where it reduced the damage caused by ischemic stroke in rats. This study sets out to investigate if it's possible to utilize Semaglutide, to increase the resilience of brain cells in patients with an acute ischemic stroke, with the aim of bettering their outcome.

The participants consist of non-diabetic patients with acute ischemic stroke, who will be randomized to:

• Treatment with subcutaneous Semaglutide, or
• No additional treatment (control group)

Both groups will be treated according to the standard national guidelies for acute ischemic stroke.

The two groups will then be compared to see, if patients in the group treated with Semaglutide are less impacted by their stroke.

Detailed Description

For detailed project description, please refer to the full trial information at the Clinical Trials Information System (see 'More information' below for link).

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Semaglutide 0.5 mg

Inj. Semaglutide 0.5 mg s.c., 0.5 mg per week for 4 weeks

+ standard care

Group Type: ACTIVE_COMPARATOR

Semaglutide

Intervention Type: DRUG

Subcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion.

Standard care

Intervention Type: OTHER

Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.

Control

Standard care

Group Type: OTHER

Standard care

Intervention Type: OTHER

Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.

Interventions

Semaglutide

Subcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion.

Intervention Type: DRUG

Standard care

Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.

Intervention Type: OTHER

Other Intervention Names

Ozempic

Eligibility Criteria

Inclusion Criteria

• Male and female patients (≥ 18 years) at the time of signed informed consent/proxy consent
• Acute ischemic stroke with disabling neurological deficits (defined as an impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect, or ataxia)
• Onset/last seen well to randomization < 4.5 hours
• None to moderate disability in daily living before symptom onset (pre-stroke modified Rankin Scale 0-3)

Exclusion Criteria

• Diabetes (known) or plasma/point of care test-glucose >11.1 mmol/L at admission
• BMI< 22
• History of pancreatitis, medullary thyroid carcinoma
• Predisposition or known Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Short remaining life expectancy (< 12months) and/or severe neurodegenerative disease
• Pregnancy or planned pregnancy within 12 months or breastfeeding
• Renal impairment measured as estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Herning Hospital

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Z Simonsen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Thomas Mellemkjaer, MD

Role: CONTACT

thomas.mellemkjaer@rm.dk

004551430175

Claus Z Simonsen, Professor

Role: CONTACT

clausimo@rm.dk

004523669875

Facility Contacts

Claus Z Simonsen, MD

Role: primary

clasim@rm.dk

004523669875

Related Links

https://euclinicaltrials.eu/view-clinical-trial?p_p_id=emactview_WAR_emactpublicportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_count=1&_emactview_WAR_emactpublicportlet_number=2022-501072-25-02&_emactview_WAR_emactpublicportlet__facesViewIdRender=%2FWEB-INF%2Fviews%2Fview%2Ftabs%2Fsummary.xhtml

Trial informaion on CTIS (Clinical Trials Information System), European Medicinal Agency

Other Identifiers

EUCT number: 2022-501072-25-02

Identifier Type: OTHER

Identifier Source: secondary_id

ASSET

Identifier Type: -

Identifier Source: org_study_id