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 (ASSET)

Conditions

Ischemic Stroke

Brief summary

A shift toward better functional outcomes in the distribution of the modified Ranking Scale (mRS) (ordinal logistic regression)

Detailed description

Proportion of patients with a Serious Adverse Events and/or Serious Unexpected Serious Adverse Events within 90 days of randomization, 90-day mortality, One-year mortality, Frequency of predefined serious adverse events, Excellent functional outcome (modified Rankin Scale 0-1) at 90 days, Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 3 months in AIS patients, Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 12 months in AIS patients, Stroke recurrence at 12 months in patients with a stroke due to small vessel disease, Early neurological improvement (NIHSS_24hour – NIHSS_baseline), Change in body weight (kg) (week 12-baseline), Change in fasting plasma glucose (week 12-baseline), Change in body mass index (BMI) (week 12-baseline), Change in waist circumference (week 12-baseline), Difference in HbA1c (week 12-baseline), Diabetes diagnosis and/or antidiabetic medication (week 52), Systolic and diastolic blood pressure (week 12 BP - discharge BP), Change in Quality of life (EQ5D, week 12- baseline), Change in Major Depression Inventory (MDI, week 12- baseline), Difference in activities of daily living - Multi Data Set –Home Care (MDS-HC, week 12), 24-hour infarct growth on DWI-MRI, Acute and long-term platelet inhibition in Semaglutide treated patients, The effect of semaglutide in non-diabetic stroke patients on insulin, c-peptide, glucagon and 3-hydroxybuturate levels, The effect of semaglutide in non-diabetic stroke patients on leptin, cholecystokinin (CCK) and gastric inhibitory polypeptide (GIP), Proportion of patients diagnosed with dementia (all-cause) at 12 months, Change in TICS score (12 months - 90 days)

Related papers

No related papers found yet.

Interventions

DRUGImodium

DRUGHjertemagnyl

DRUGfilmovertrukne tabletter 75 mg

DRUGOzempic 0.5 mg solution for injection in pre-filled pen

DRUGOzempic 0.25 mg solution for injection in pre-filled pen

DRUGOndansetron Fresenius Kabi 2 mg/ml solution injectable

DRUGActilyse

DRUGpulver og solvens til injektions-/infusionsvæske

DRUGopløsning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
A shift toward better functional outcomes in the distribution of the modified Ranking Scale (mRS) (ordinal logistic regression)	—

Secondary

Measure	Time frame
Proportion of patients with a Serious Adverse Events and/or Serious Unexpected Serious Adverse Events within 90 days of randomization, 90-day mortality, One-year mortality, Frequency of predefined serious adverse events, Excellent functional outcome (modified Rankin Scale 0-1) at 90 days, Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 3 months in AIS patients, Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 12 months in AIS patients, Stroke recurrence at 12 months in patients with a stroke due to small vessel disease, Early neurological improvement (NIHSS_24hour – NIHSS_baseline), Change in body weight (kg) (week 12-baseline), Change in fasting plasma glucose (week 12-baseline), Change in body mass index (BMI) (week 12-baseline), Change in waist circumference (week 12-baseline), Difference in HbA1c (week 12-baseline), Diabetes diagnosis and/or antidiabetic medication (we	—

Measure

Time frame

Proportion of patients with a Serious Adverse Events and/or Serious Unexpected Serious Adverse Events within 90 days of randomization, 90-day mortality, One-year mortality, Frequency of predefined serious adverse events, Excellent functional outcome (modified Rankin Scale 0-1) at 90 days, Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 3 months in AIS patients, Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 12 months in AIS patients, Stroke recurrence at 12 months in patients with a stroke due to small vessel disease, Early neurological improvement (NIHSS_24hour – NIHSS_baseline), Change in body weight (kg) (week 12-baseline), Change in fasting plasma glucose (week 12-baseline), Change in body mass index (BMI) (week 12-baseline), Change in waist circumference (week 12-baseline), Difference in HbA1c (week 12-baseline), Diabetes diagnosis and/or antidiabetic medication (we

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Countries

Denmark

Outcome results

None listed