Acute Subcutaneous Semaglutide in Acute Ischemic Stroke (ASSET Trial)

Phase 1

Recruiting

• Conditions: Ischemic Stroke; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-501072-25-02
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 380

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, or DWI-FLAIR mismatch on MRI in patients with unknown time of onset and < 4,5 hours since symptoms were acknowledged, 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, History of renal impairment (estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m2)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified