Acute Ischaemic Stroke
Conditions
Interventions
Trade Name: Metalyse
Product Name: Tenecteplase
Product Code: NA
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Actilyse
Product Name: Alteplase
Product Code: NA
Pharm
Sponsors
Hospital Vall Hebron
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients eligible to undergo intravenous thrombolysis (tPA or TNK) within 4.5 hours after the onset of ischemic stroke. • Cerebral vascular occlusion on CT angiography of the intracranial ICA, MCA M1 or MCA M2 and if EVT could start (arterial puncture) within 6 hours after stroke onset. • Age >18 y.o • Men and women (women with child-bearing potential are excluded). • A new focal disabling neurologic deficit consistent with acute cerebral ischemia. • Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative), or Differed Inform Consent (DIC) to avoid any delay in the initiation of iv thrombolysis. The DIC will be sign by the patient or next of kin at any time after the tPA or TNK treatment is started. 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Patients with severe preexisting disability, defined as a modified Rankin scale score >3. • Glasgow Coma Scale score = 7. • Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0. • Baseline platelet count 400 mg/dL. • Severe, sustained and uncontrollable hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg). • Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months. • Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas). • Patient participating in a study involving an investigational drug or device that would impact this study. • Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Shift analysis of the modified Rankin scale score at 3 months;Timepoint(s) of evaluation of this end point: 3 months;Main Objective: The aim of the present study is to determine the safety and efficacy of TNK (0.25mh/kg) compared to tPA (0.9 mg/kg) in LVO patients candidates for EVT in both Mothership and Drip-and-Ship scenarios.;Secondary Objective: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rates of mRS 0-2 at 3 months - Rates of pre-interventional recanalization - Dramatic clinical recovery before EVT (Improvement in > 8 point in the NIHSS jscore or NIHSS score < 2 before groin puncture) - Rates of first pass TICI 3, final TICI 2b-3 - Rates of distal embolization during EVT - Differences in needle-to-groin times in Mothership patients and in DIDO times in Drip-and-Ship patients. - Differences in time metrics between TNKCAT and non-TNKCAT centers - Differences in final infarct volume on follow up CT;Timepoint(s) of evaluation of this end point: 3 months and at baseline | — |
Countries
Spain
Contacts
Public ContactEstela Sanjuan
Hospital Vall Hebron
Outcome results
None listed