Patients with acute ischemic stroke, treated with intravenous thrombolysis treatment according to the European regulatory criteria
Conditions
Interventions
Trade Name: BYETTA
Pharmaceutical Form: Injection
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute ischemic stroke patient treated with intravenous thrombolysis 2. Age 18 years or above 3. Intravenous thrombolysis therapy is given within 4.5h of stroke onset. 4. Plasma glucose between 7.1 and 9.9 mmol/L prior to start of intravenous thrombolysis 5. Able to commence plasma glucose lowering regimen within 1 h of completion of intravenous thrombolysis therapy 6. Able to be ‘actively’ treated and admitted to a monitored facility, such as an acute stroke unit, high dependency unit or intensive care unit. 7. Informed consent from patient. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Previous known diabetes (type 1 or type 2 DM) or ongoing medication with any glucose-lowering agent. 2. A very high likelihood that the patient will die within the next 24 h on the basis of clinical and/or radiological criteria (e.g. malignant media infarct). 3. Patients expected to require endovascular or surgical intervention (e.g. i.a. thrombolysis or mechanical thrombectomy, carotid endarterectomy) during the treatment or follow-up period. 4. Previous participation in this trial or current participation in another investigational stroke treatment clinical trial 5. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen 6. Plasma glucose =10.0 mmol/L 7. Patients with lower level of consciousness (Glasgow Coma Scale 0 in item 9) or Verbal response <5 in Glasgow Coma Scale)* 13. Patients with known severe renal failure (creatinine clearance < 30 ml/min) *Patient may be included in case of mild dysphasia (NIHSS=1 in item 9) provided that the NIHSS is performed by a physician and a witness not involved in the trial verify that the patient fully understand information provided to be included in the trial and then gives consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the safety of normalising of slightly elevated plasma glucose by exenatide (Byetta) in acute ischaemic stroke patients treated with intravenous rt-PA therapy • To investigate whether it is feasible to normalise of slightly elevated plasma glucose by exenatide (Byetta) in acute ischaemic stroke patients treated with intravenous rt-PA therapy ;Secondary Objective: • To determine the ischaemic lesion volume and brain oedema on 22-36h post-thrombolysis CT-scan in patients treated with exenatide (Byetta) compared to control • To examine the levels of neuronal damage and inflammation markers in patients treated with exenatide (Byetta) compared to control after stroke-thrombolysis • To investigate the mortality and functional independency at 3 months ;Primary end point(s): • The primary safety outcome is a composite endpoint which is reached if any of the following events has occurred: Any serious or intolerable non-serious adverse events, death within 7 days, or symptomatic intracerebral haemorrhage (SICH) per SITS-MOST definition within 24 hours. • Primary feasibility/efficacy outcome: At least 80% of the plasma glucose measurements are within the target intervals (5-7 mmol/L) over time (72 hours) in each patient and if 80% (24 of 30) of patients in the treatment group fulfil this criterion. ;Timepoint(s) of evaluation of this end point: • Composite endpoint which is reached if any of the following events has occurred: Any serious or intolerable non-serious adverse events, death within 7 days, or symptomatic intracerebral haemorrhage (SICH) per SITS-MOST definition within 24 hours. • Primary feasibility/efficacy outcome: At least 80% of the plasma glucose measurements are within the target intervals (5-7 mmol/L) over time (72 hours) in each patient and if 80% (24 of 30) of patients in the treatment group fulfil this criterion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Ischemic lesion volume and brain oedema determined on CT-scans at day 2 • Pulse rate (measured every 4th hour from randomization to 72 hours after randomization) • Levels of markers of neuronal damage (i.e. S 100B) • Levels of markers of inflammation (i.e. hs-CRP, IL 6, PAI-1 and TNF-a) • SICH per ECASS-2 definition. • Functional independency as measured by modified Rankin scale (mRS) score of 0-2 at 3 months • Death within 3 months ;Timepoint(s) of evaluation of this end point: • Ischemic lesion volume and brain oedema determined on CT-scans at day 2 • Pulse rate (measured every 4th hour from randomization to 72 hours after randomization) • Levels of markers of neuronal damage (i.e. S 100B) after 24 hours • Levels of markers of inflammation (i.e. hs-CRP, IL 6, PAI-1 and TNF-a) after 24 hours • SICH per ECASS-2 definition. • Functional independency as measured by modified Rankin scale (mRS) score of 0-2 at 3 months • Death within 3 months | — |
Countries
Sweden
Contacts
Public ContactKarolinska University Hospital
Karolinska University Hospital
Outcome results
None listed