Stroke, cerebral ischemia
Conditions
Interventions
Patients will be included in an alternating fashion between group 1 (treatment upon diagnosis) and group 2a/b (treatment after successful reperfusion). Patients allocated to treatment upon reperfusion
Sponsors
Haaglanden Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: • Adults (age > 18 years for males and age >49 years for females) • A clinical diagnosis of AIS • Disabling stroke defined as a baseline NIH stroke scale score =5 • Alberta Stroke Program Early CT score (ASPECTS) > 4 on CT (or MRI) • Presence of an intracranial LVO of the anterior circulation (distal ICA, M1 or proximal M2 segment of the MCA) on CTA, MRA or DSA • Start of EVT (arterial access puncture) possible within the first 6 hours after stroke onset or last seen well • EVT with declared first endovascular approach as either stent retriever, aspiration device or a combined approach • Written informed consent (after deferred consent) • Pre-stroke independent functional status in activities of daily living (mRS=2)
Exclusion criteria
Exclusion criteria: • No informed consent • Contraindication to EVT or EVT > 6 hours after symptom onset (or last seen well) • Evidence of a large core of established infarction defined as ASPECTS 0-4. • Evidence of absence/poor collateral circulation on CTA (Tan collateral score of 0 or 1)26. • Known co-morbidity with a life expectancy of 2 • Intent to use any endovascular device other than a stent retriever or clot aspiration device or intra-arterial medications as the initial thrombectomy approach. • History of life threatening allergy (more than rash) to contrast medium • Evidence of acute hemorrhage on CT, MRI · Significant mass effect with midline shift. · Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) · Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or if known a eGFR < 20 mL/min. *As 2-IB has not been tested yet for embryonic toxicity and limited pre- and postnatal development studies have been performed, women who can be pregnant must not be included be in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters used for evaluating the short-term safety and tolerability will be vital signs (heart frequency, blood pressure and oxygen saturation) before and during 24 hours after administration of the study drug and the need for clinical intervention. Furthermore, the occurrence of adverse and serious adverse events until 7 days will be recorded on the neurology department or until discharge from the neurology department, whichever occurs earlier. For evaluation of the pharmacokinetics profile of 2-IB, 4 plasma samples will be analysed at different intervals (4 hours, 24 hours, 25 hours, and 28 hours after study medication) Pharmacokinetic parameters to be determined will include Cmax, AUC, Tmax, T1/2, clearance (Cl), and volume of distribution (Vd). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stroke Severity measured with the NIH stroke scale (NIHSS) at 24 hours and at discharge or at 7 days, whichever occurs earlier. 2. Infarct volume measured with MRI at 24-48 hours. In case of contraindication(s) for MRI, CT/CTA will be performed at day 5 or discharge. 3. Embolization in new territory on angiography during EVT or infarction in new territory on 24-48h MRI (or CT) 4. Vessel recanalization at 24 hours with MRA (or CTA in case of contraindications for MRI) 5. Any postintervention intracranial haemorrhage on neuroimaging within 48 hours. 6. Blood investigation (CBC, electrolytes, serum creatinine, serum glucose) at 24 hours 7. Blood investigation, single biomarker neurofilament light chain at 24 hours and at 7 days or discharge from hospital, whichever occurs earlier. 8. Cognitive assessment using the Cognitive Assessment scale for Stroke Patients (CASP) at 7 days or at discharge from hospital, whichever occurs earlier Additional parameters In addition to the primary and secondary outcome parameters, the percentage of patients with successful vessel recanalization defined as eTICI score grade 2b, 2c and 3 will be recorded. Also the percentage of patients with IVT in each group will be noted. | — |
Contacts
Public ContactErik Vos
Haaglanden Medisch Centrum
Outcome results
None listed