Cerebral Embolectomy in patients with acute stroke
Conditions
Interventions
Trade Name: Actilyse
Product Name: Actilyne
Pharmaceutical Form: Solvent for solution for infusion
INN or Proposed INN: ALTEPLASE
CAS Number: 105857-23-6
Current Sponsor code: CHOICE
Other descriptive
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with symptomatic large vessel occlusion (LVO) in the anterior, middle or posterior cerebral arteries treated with MT resulting in a mTICI score 2b at end of the procedure 2. Estimated delay to onset of rescue intraarterial rt-PA or placebo administration 6 on non-contrast CT (NCCT) scan if symptoms lasting 6 on CT-Perfusion (CTP) if symptoms >4.5 =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. NIHSS score on admission >25 2. Contraindication to IV t-PA as per local national guidelines (except time to therapy) 3. Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy 4. Female who is pregnant or lactating or has a positive pregnancy test at time of admission 5. Current participation in another investigation drug or device treatment study (except observational study i.e.: RACECAT) 6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency 7. Known coagulopathy, INR >1.7 or use of novel anticoagulants 3.0 mg/dl (or 265.2 µmol/l) or glomerular Filtration Rate [GFR] 185 mmHg or DBP >110 mmHg refractory to treatment 17. Serious, advanced, terminal illness with anticipated life expectancy <6 months 18. Pre-existing neurological or psychiatric disease that would confound evaluation 19. Presumed vasculitis or septic embolization 20. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objective is to evaluate whether rt-PA is safe and efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and complete or near-complete recanalization of a proximal vessel occlusion but partial brain reperfusion on cerebral angiogram >50% and <91% brain reperfusion on cerebral angiography (corresponding to mTICI score 2b);Secondary Objective: • The shift analysis of the modified Rankin Scale (mRS), at day 90. The mRS at 90 days will be analyzed using a proportional odds model (POM) that combine into single worst rank the last two categories (5: severe incapacity and 6: death). • Infarct Expansion Ratio on DWI-MRI (continuous variable), at 24h of stroke • Proportion of patients with excellent outcome (mRS 0-1) at day 90 • Proportion of patients with/without infarct expansion (dichotomous variable) • Infarction Volume on DWI-MRI, at 24h of stroke onset;Primary end point(s): The proportion of patients with an improved mTICI score ten (10) minutes after the end of study treatment will be estimated using a log-binomial regression model including the stratification variables, except centre. In the unexpected event that the model does not fit, the Poisson regression model with long-link and robust variance estimator will be used instead;Timepoint(s) of evaluation of this end point: 10 minutes after the end of the study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The shift analysis of the modified Rankin Scale (mRS), at day 90. The mRS at 90 days will be analyzed using a proportional odds model (POM) that combine into single worst rank the last two categories (5: severe incapacity and 6: death). • Infarct Expansion Ratio on DWI-MRI (continuous variable), at 24h of stroke • Proportion of patients with excellent outcome (mRS 0-1) at day 90 • Proportion of patients with/without infarct expansion (dichotomous variable) • Infarction Volume on DWI-MRI, at 24h of stroke onset;Timepoint(s) of evaluation of this end point: según variable | — |
Countries
Spain
Contacts
Public ContactClinical Trial information
ANAGRAM-ESIC. S.L.
Outcome results
None listed