E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061256 |
E.1.2 | Term | Ischaemic stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Forsøget har til formål at undersøge, hvordan en engangsdosis af medicinen exenatid 5 mikrogram GLP-1 receptor agonist ( exenatid) , givet subkutant, sammenholdt med uvirksom medicin (placebo) påvirker blodgennemstrømningshastigheden og den cortikale iltmætning i hjernens store kar hos patienter som har blodprop i hjernen. |
|
E.2.2 | Secondary objectives of the trial |
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. |
Sekundære formål med forsøget er, at undersøge GLP-1-RAs virkning på blodkarfunktionen perifert på fingrene målt ved EndoPAT og perifert i anklerne målt som ankel-brachialindex (ABI), samt at undersøge endothelfunktion og inflammation via specifikke biomarkører. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
• Patienter ≥ 18 år med nyopståede symptomer på blodprop i hjernen
• Skal kunne modtage GLP-1-RA/placebo-medicin indenfor 21 dage efter debut af symptomer
• Radiologisk verificeret diagnose af blodprop i hjernen
• NIHSS mellem 1-20 ved symptomdebut
• mRS ≤ 2 før symptomdebut
• Har afgivet skriftligt informeret samtykke
|
|
E.4 | Principal 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 |
• Intracerebral blødning
• Subdural/epidural blødning
• Subarachnoidal blødning
• Tidl. større strukturel skade på hjernen (eks. sequelae efter tidl. stor blodprop eller hjernekirurgi)
• Type 1 sukkersyge
• Type 2 sukkersyge
• Kendt atrieflimmer
• > 50% stenose af halskar
• Kendt allergi overfor GLP-1-RA præparater
• Nedsat leverfunktion (ALAT > 3 x øvre normalgrænse)
• Nedsat nyrefunktion (eGFR < 30 ml/min)
• Inflammatorisk tarmsygdom
• Tidligere pancreatit
• Hjertesvigt (NYHA klasse 3-4)
• Graviditet eller amning
• Patient der ikke forventes at kunne kooperere til undersøgelserne
• Visualisering af a. cerebri medicin bilateralt ved transkraniel doppler ej mulig
|
|
E.5 End points |
E.5.1 | 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. |
Primær endpoint er ændringer i blodets middelstrømningshastighed (Vmean ) i a. cerebri media og den corticale iltmætning . |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to three hours after injection of exenatid. |
Op til tre timer efter injektion af exenatid. |
|
E.5.2 | 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. |
- Ændring i perifert karfunktion målt med EndoPAT og ændringer i ankel-brachial-indexet
- Ændring af inflammatoriske- og karspecifikke markører i blodet.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to three hours after injection of exenatid. |
Op til tre timer efter injektion af exenatid. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |