Acute stroke
Conditions
Interventions
Trade Name: Actilyse
Product Name: Actilyse
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
INN or Proposed INN: ALTEPLASE
CAS Number: 105857-23-6
Concentration unit:
Sponsors
Med. Uni. Wien, UK für Neurologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age between 18 – 80 years • Clinical syndrome of a severe ischemic lesion within the anterior circulation („Total Anterior Circulation Syndrome“ TACS) or of basilar artery occlusion • NIHSS > 12 • Start of IVT within 3 hours („bridging“, „rescue“) or within 4.5 hours (`primary endovascular management`) • Confirmation of proximal occlusion • Absence of exclusion criteria 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: • History of stroke within the last 3 months • History of subarachnoid or intracranial hemorrhage, known cerebrovascular arteriovenous malformation or CNS tumour • Clinical suggestion of subarachnoid hemorrhage and negative CT • Uncontrolled systolic blood pressure • Evidence of septic embolism etiologically related to stroke • Evidence of pericarditis including pericarditis after myocardial infarction • Operation or biopsy of a body organ within the last 30 days (not an exclusion criterion for primary endovascular treatment) • Trauma with inner or outer ulcerous wounds within the last 30 days (not an exclusion criterion for primary endovascular treatment) • Severe head trauma or concussion within the last 90 days • Current bleeding • Systemic bleeding (outside the head) within the last 30 days (not an exclusion criterion for primary endovascular treatment) • Known hereditary or acquired hemorrhagic diathesis , known hereditary or acquired coagulation factor deficiency; oral anticoagulation and a prolonged prothrombin time (INR > 1.5) • Women of childbearing age with known pregnancy or positive pregnancy test • Baseline platelet count 1/3 of MCA territory) MR-criteria: • Extensive diffusion lesion (> 1/3 of MCA territory) • No mismatch (at the discretion of treating neurologists/radiologists)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary hypothesis of this study is that the percentage of patients with good clinical outcome after 3 months (mRS 0-2) is increased compared to patients treated with standard IVT (as documented within the Austrian Stroke Unit registry) when adjusted for relevant outcome parameters (age, stroke severity, vascular territory, diabetes and onset to treatment time).;Secondary Objective: •mortality after 3 months compared to matched patients treated with standard IVT (as documented within the Austrian Stroke Unit registry) •symptomatic intracranial hemorrhage (according to NINDS and SITS MOST/dB3 criteria) compared to matched patients treated with standard IVT (as documented within the Austrian Stroke Unit registry) •excellent clinical outcome after 3 months as measured by a modified Rankin Scale of 0-1 •causes of mortality after 3 months •percentage of patients with rapid improvement (> 4 points of the NIHSS) within the first 24 hours •Complete or partial recanalisation (TIMI 2 or 3) at the end of endovascular therapy, time to recanalisation; association between time to recanalisation and probability of good clinical outcome (mRS 0-2) after 3 months ;Primary end point(s): Modified Rankin Scale Score 0-2 after 3 months;Timepoint(s) of evaluation of this end point: 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mortality after 3 months Incidence of symptomatic intracranial hemorrhage ;Timepoint(s) of evaluation of this end point: 3 month | — |
Countries
Austria
Contacts
Public ContactProf. W. Serles
Med. Uni. Wien, UK für Neurologie
Outcome results
None listed