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NCT Number: NCT05630586

Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location status: Recruiting

Location contact

Claus Z Simonsen, MD

CONTACT

[email protected]

004523669875

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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

Other names: Ozempic

Standard care

Other

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

Primary outcomes

  1. Modified Ranking Scale

    Time frame: 90 (+/- 14) days

    A shift towards better functional outcomes in the distribution of the modified Ranking Scale (mRS)

Secondary outcomes

  1. Serious Adverse Events and/or Serious Unexpected Serious Adverse Events

    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

  2. 90-day mortality

    Time frame: 90 days

  3. One-year mortality

    Time frame: 1 year

  4. Predefined SAEs

    Time frame: 1 year

    Frequency of predefined serious adverse events

  5. Excellent functional outcome at 90 days

    Time frame: 90 (+/- 14) days

    mRS score of 0-1

  6. MACCE and recurrent ischemic events, 90 days

    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

  7. MACCE and recurrent ischemic events, 12 months

    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

  8. Stroke recurrence at 12 months in patients with a stroke due to small vessel disease

    Time frame: 12 months

  9. Early neurological improvement

    Time frame: 24 (+/- 8) hours

    NIHSS_24hour - NIHSS_baseline (NIHSS National Institutes of Health Stroke Scale)

  10. Change in body weight (kg)

    Time frame: 90 (+/- 14) days

    90 days - baseline

  11. Change in fasting plasma glucose

    Time frame: 90 (+/- 14) days

    90 days - baseline

  12. Change in body mass index (BMI)

    Time frame: 90 (+/- 14) days

    90 days - baseline

  13. Change in waist circumference

    Time frame: 90 (+/- 14) days

    90 days - baseline

  14. Difference in HbA1c

    Time frame: 90 (+/- 14) days

    90 days - baseline

  15. Diabetes diagnosis and/or antidiabetic medication

    Time frame: 12 months

    Diagnosed with and/or started antidiabetic medication within 1 year of enrollment

  16. Blood pressure, 90 days

    Time frame: 90 (+/- 14) days

    Systolic and diastolic blood pressure (90 days BP - discharge BP)

Other outcomes

  1. Patient reported outcome: Quality of Life (QoL)

    Time frame: 90 (+/- 14) days

    European Quality of Life - 5 Dimension (EQ5D), 90 days - baseline

  2. Patient reported outcome: Major Depression Inventory (MDI)

    Time frame: 90 (+/- 14) days

    Change in MDI (90 days - baseline)

  3. Patient reported outcome: SSQOL-DK

    Time frame: 90 (+/- 14) days

    Difference in Stroke Specific Quality of Life Scale (SSQOL-DK, 90 days)

  4. Patient reported outcome: Activities of daily living

    Time frame: 90 (+/- 14) days

    Difference in activities of daily living - Multi Data Set -Home Care (MDS-HC,90 days)

  5. Sub-study: 24-hour infarct growth

    Time frame: 24 (+/-8) hours

    Infarct growth on diffusion-weigthed magnetic resonance imaging (DWI-MRI). Aarhus University Hospital (AUH) only

  6. Sub-study: Acute and long-term platelet inhibition in Semaglutide treated patients

    Time frame: 90 (+/- 14) days

    AUH only

  7. Sub-study: The effect of semaglutide in non-diabetic stroke patients on insulin, c-peptide, glucagon and 3-hydroxybuturate levels

    Time frame: 90 (+/- 14) days

    AUH only

  8. Sub-study: The effect of semaglutide in non-diabetic stroke patients on leptin, ghrelin, cholecystokinin (CCK) and gastric inhibitory polypeptide (GIP)

    Time frame: 90 (+/- 14) days

    AUH only

Study contacts

Contact information is provided by the study sponsor or research team.

Claus Z Simonsen, Professor

CONTACT

[email protected]

004523669875

Thomas Mellemkjaer, MD

CONTACT

[email protected]

004551430175

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Bispebjerg Hospital
  • Glostrup University Hospital, Copenhagen
  • Herning Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Nov 29, 2022
Registry last updated
Apr 25, 2023

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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