Aarhus University Hospital
Aarhus, 8000, Denmark
Location status: Recruiting
NCT Number: NCT05630586
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Aarhus, 8000, Denmark
Location status: Recruiting
For detailed project description, please refer to the full trial information at the Clinical Trials Information System (see 'More information' below for link).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion.
Other names: Ozempic
Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.
Time frame: 90 (+/- 14) days
A shift towards better functional outcomes in the distribution of the modified Ranking Scale (mRS)
Time frame: 90 days
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
Time frame: 1 year
Time frame: 1 year
Frequency of predefined serious adverse events
Time frame: 90 (+/- 14) days
mRS score of 0-1
Time frame: 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: 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
Time frame: 24 (+/- 8) hours
NIHSS_24hour - NIHSS_baseline (NIHSS National Institutes of Health Stroke Scale)
Time frame: 90 (+/- 14) days
90 days - baseline
Time frame: 90 (+/- 14) days
90 days - baseline
Time frame: 90 (+/- 14) days
90 days - baseline
Time frame: 90 (+/- 14) days
90 days - baseline
Time frame: 90 (+/- 14) days
90 days - baseline
Time frame: 12 months
Diagnosed with and/or started antidiabetic medication within 1 year of enrollment
Time frame: 90 (+/- 14) days
Systolic and diastolic blood pressure (90 days BP - discharge BP)
Time frame: 90 (+/- 14) days
European Quality of Life - 5 Dimension (EQ5D), 90 days - baseline
Time frame: 90 (+/- 14) days
Change in MDI (90 days - baseline)
Time frame: 90 (+/- 14) days
Difference in Stroke Specific Quality of Life Scale (SSQOL-DK, 90 days)
Time frame: 90 (+/- 14) days
Difference in activities of daily living - Multi Data Set -Home Care (MDS-HC,90 days)
Time frame: 24 (+/-8) hours
Infarct growth on diffusion-weigthed magnetic resonance imaging (DWI-MRI). Aarhus University Hospital (AUH) only
Time frame: 90 (+/- 14) days
AUH only
Time frame: 90 (+/- 14) days
AUH only
Time frame: 90 (+/- 14) days
AUH only
Contact information is provided by the study sponsor or research team.
Claus Z Simonsen, Professor
CONTACT
Thomas Mellemkjaer, MD
CONTACT
Aarhus University Hospital
Other
The Safety and Efficacy of Acute Subcutaneous Administration of Semaglutide in Non-diabetic Patients With Acute Ischemic Stroke: A Multicentre, Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint Trial
Acronym: ASSET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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