Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05630586

Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

Led by Aarhus University Hospital · Updated on 2023-04-25

380

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

Sponsors

A

Aarhus University Hospital

Lead Sponsor

B

Bispebjerg Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients 18 years or older at the time of consent
  • Acute ischemic stroke with disabling neurological deficits affecting language, motor function, cognition, gaze, vision, neglect, or ataxia
  • Stroke onset or last known well to randomization less than 4.5 hours
  • None to moderate disability in daily living before stroke (pre-stroke modified Rankin Scale 0-3)
Not Eligible

You will not qualify if you...

  • Known diabetes or blood glucose over 11.1 mmol/L at admission
  • Body mass index (BMI) less than 22
  • History of pancreatitis or medullary thyroid carcinoma
  • Known predisposition to Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Short life expectancy under 12 months or severe neurodegenerative disease
  • Pregnancy, planned pregnancy within 12 months, or breastfeeding
  • Kidney impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2

AI-Screening

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Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Denmark, 8000

Actively Recruiting

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Research Team

T

Thomas Mellemkjaer, MD

CONTACT

C

Claus Z Simonsen, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke | DecenTrialz