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.
For detailed project description, please refer to the full trial information at the Clinical Trials Information System (see 'More information' below for link).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
380
Subcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion.
Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGModified Ranking Scale
A shift towards better functional outcomes in the distribution of the modified Ranking Scale (mRS)
Time frame: 90 (+/- 14) days
Serious Adverse Events and/or Serious Unexpected Serious Adverse Events
Proportion of patients with Serious Adverse Events (SAE) and/or Serious Unexpected Serious Adverse Events (SUSAR) within 90 days of randomization
Time frame: 90 days
90-day mortality
Time frame: 90 days
One-year mortality
Time frame: 1 year
Predefined SAEs
Frequency of predefined serious adverse events
Time frame: 1 year
Excellent functional outcome at 90 days
mRS score of 0-1
Time frame: 90 (+/- 14) days
MACCE and recurrent ischemic events, 90 days
Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 3 months in AIS patients
Time frame: 90 days
MACCE and recurrent ischemic events, 12 months
Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 12 months in AIS patients
Time frame: 12 months
Stroke recurrence at 12 months in patients with a stroke due to small vessel disease
Time frame: 12 months
Early neurological improvement
NIHSS\_24hour - NIHSS\_baseline (NIHSS National Institutes of Health Stroke Scale)
Time frame: 24 (+/- 8) hours
Change in body weight (kg)
90 days - baseline
Time frame: 90 (+/- 14) days
Change in fasting plasma glucose
90 days - baseline
Time frame: 90 (+/- 14) days
Change in body mass index (BMI)
90 days - baseline
Time frame: 90 (+/- 14) days
Change in waist circumference
90 days - baseline
Time frame: 90 (+/- 14) days
Difference in HbA1c
90 days - baseline
Time frame: 90 (+/- 14) days
Diabetes diagnosis and/or antidiabetic medication
Diagnosed with and/or started antidiabetic medication within 1 year of enrollment
Time frame: 12 months
Blood pressure, 90 days
Systolic and diastolic blood pressure (90 days BP - discharge BP)
Time frame: 90 (+/- 14) days
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