Stroke MedDRA version: 19.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Herlev Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients = 18 years with new-onset symptoms of stroke • Must be able to receive GLP-1 RA / placebo medication within 21 days after the onset of symptoms • Radiological verified diagnosis of stroke • NIHSS between 1-20 at the onset of symptoms • mRS = 2 prior to onset of symptoms • Has given written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Intracerebral haemorrhage • Subdural / epidural hemorrhage • subarachnoid haemorrhage • previously major structural damage to the brain (eg. sequelae after large stroke or brain surgery) • Type 1 diabetes • Type 2 diabetes • Known atrial fibrillation • > 50% stenosis of halskar • Known allergy to GLP-1 RA preparations • Hepatic impairment (ALT> 3 x upper normal limit) • Renal impairment (eGFR <30 ml / min) • Inflammatory bowel disease • Previous pancreatitis • Heart failure (NYHA class 3-4) • Pregnancy or lactation • Patient is not expected to co-operate to the investigations • Visualization of the middle cerebral artery bilaterally by transcranial doppler not possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate the effect of a single dose of 5 mikrogram GLP-1 receptor agonist ( exenatid ) on blood flow velocity and cortical oxigination in patients with iscaemic stroke. ;Secondary Objective: Secondary objectives of this study is to investigate if the GLP-1 receptor agonist ( exenatid ) improves the peripheral endothelial function measured as an improved blood vessel respons in the fingers after a short occlusion of blood suply to the arm measured with endoPAT2000 and by measuring the blood pressure in the ancles (ancle-brachial index). Besides of that is the objective to examine the endothelial function, and inflammation through specific biomarkers.;Primary end point(s): Primary endpoint is changes in the mean blood flow velocity (Vmean) in the middle cerebral artery and in the cortical oxigination.;Timepoint(s) of evaluation of this end point: Up to three hours after injection of exenatid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in peripheral vascular function measured by EndoPAT and changes in the ancle-brachial index - Changes in inflammatory- and endothelial function markers in the blood.;Timepoint(s) of evaluation of this end point: Up to three hours after injection of exenatid. | — |
Countries
Denmark
Contacts
Public ContactChristina Rostrup Kruuse
Herlev Gentofte Hospital
Outcome results
None listed