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)

Aarhus University Hospital0 个研究点目标入组 380 人开始时间: 2022年8月22日最近更新: 2024年7月22日

适应症

试验速览

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•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)

•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)

发起方

Aarhus University Hospital