Acute Anterior Circulation Stroke
Conditions
Interventions
Trade Name: Actilyse
International Non-Proprietary Name (INN): Alteplase
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ALTEPLASE
CAS Number: 105857-23-6
Concentration unit
Sponsors
Universtiy Hospital Bern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent as documented by signature - Age = 18 years - Clinical signs consistent with an acute ischaemic stroke - Neurological deficit with a NIHSS of = 5 and =65 years) yes F.1.3.1 Number of subjects for this age range 102
Exclusion criteria
Exclusion criteria: • Acute intracranial haemorrhage • Any contraindication for IV t-PA • Pre-treatment with IV t-PA • In-hospital stroke • Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential. • Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys • Known current participation in a clinical trial • Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min and /or known history of renal insufficiency or requirement for haemodialysis or peritoneal dialysis • Severe comorbid condition with life expectancy less than 90 days at baseline • Known advanced dementia or significant pre-stroke disability (mRS score of = 2) • Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) • Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments. • Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day). • Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT • Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma) • Radiological confirmed evidence of cerebral vasculitis • CTA or MRA evidence of carotid dissection • Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this RCT is to measure the effect of direct mechanical thrombectomy (MT) compared with bridging thrombectomy (combined IV t-PA and MT). The primary objective is to determine whether subjects experiencing an acute ischemic stroke due to large intracranial vessel occlusion in the anterior circulation who are referred to a stroke centre with endovascular facilities and who are candidates for IV t-PA will have non-inferior functional outcome at 90 days when treated with direct MT compared to subjects treated with combined IV t-PA and MT. ;Secondary Objective: Secondary objectives are to study mortality, dependency, time to reperfusion and quality of life. ;Primary end point(s): The primary outcome is assessed at 90 ± 15 days after randomization by a treatment-blinded certified person during the clinical visit or by a structured telephone interview by a trained person at the trial site (according to local clinical routine). ;Timepoint(s) of evaluation of this end point: 90 ± 15 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - All-cause mortality at 90 days: Mortality will be assessed by the mRS during the clinical visit (7-10 days or discharge or 90 day ± 15 days) or by a structured telephone interview (90 ± 15 days) according to local clinical routine. If patients/relatives do not respond the general practitioner or treating physician will be contacted. - Degree of disability or dependence at 90 days as assessed by the mRS (shift analysis): Disability and dependency are assessed using the mRS during the clinical visit (7-10 days or discharge and 90 ± 15 days) or during the structured telephone interview (90 ± 15 days) according to local clinical routine. If patients/relatives do not respond the general practitioner or treating physician will be contacted. - Change in NIHSS at 24 ± 6 hours post randomization: NIHSS will be assessed at day 0, at 24 ± 6 hours post-randomization, at day 7-10 or discharge and at 90 ± 15 days after randomization during the clinical visit by an independent trained neurologist. Time from arrival at emergency department to reperfusion (mTICI = 2b): Time points will be assessed at day 0 from arrival at hospital until end of intervention. Additional important treatment time points will be recorded optionally by using the Bernese Stroke clock. mTICI is defined as:37 Grad 0 = No perfusion Grade 1 = Antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion Grade 2 = Antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (eg, in 1 major division of the MCA and its territory) Grade 3 = Antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (eg, in 2 major divisions of the MCA and their territories - Quality of life as assessed by the EuroQol 5D-3L at 90 days: Quality of life will be assessed at 90 ± 15 days after randomization using the validated EuroQol 5D-3L questionnaire during the clin | — |
Countries
Austria, Canada, Finland, France, Germany, Spain, Switzerland, United Kingdom
Contacts
Public ContactNeuroclinical Trial Unit
University Hospital Bern
Outcome results
None listed