Acute Ischemic Stroke MedDRA version: 9.1 Level: LLT Classification code 10061256 Term: Ischaemic stroke
Conditions
Interventions
Trade Name: ACTILYSE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Alteplase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CLINICAL INCLUSION CRITERIA - Sudden focal neurological deficit attributable to a stroke - Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset. -Age greater than 18 years 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: CLINICAL AND LABORATORY EXCLUSION CRITERIA - Disability preceding stroke consistent with a modified Rankin scale score of 2-4 - Coma at onset - Rapidly improving neurological deficit - Seizure at onset - Clinical presentation suggestive of a subarachnoid hemorrhage - Previous history of intracranial hemorrhage - Septic embolism - Arterial puncture at a non compressible site within the previous 7 days - Any traumatic brain injury within the previous 14 days - Surgery of the central nervous system in the previous 3 months - Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 14 days. - Current therapy with intravenous or subcutaneous heparin to rise the clotting time - Known hereditary or acquired hemorrhagic diathesis, baseline INR greater than 1.5, aPTT more than 1.5 times normal, or baseline platelet count less than 100,000 per cubic millimeter - Baseline blood glucose concentrations below 2.75 mm/L (50 mg/dL). - Known contrast sensitivity. - Women of childbearing potential (unless pregnancy impossible) or known to be breastfeeding. - Uncontrolled hypertension defined by a blood pressure greater or equal 185 mmHg systolic or diastolic greater or equal 110 mm Hg in 3 separate occasions at least 10minutes apart or requiring continuous IV therapy. - Prognosis very poor regardless of therapy; likely to be dead within months. - Unlikely to be available for follow-up (eg, no fixed home address, visitor from overseas). - Any other condition which local investigators feels would pose a significant hazard in terms of risk/benefit to the patient, or if therapies are impracticable. COMPUTED TOMOGRAPHIC(CT)SCAN EXCLUSION CRITERIA: - Intracranial tumors except small meningioma - Hemorrhage of any degree - Acute infarction (since this may be an indicator that the time of onset is uncorrected)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary aims: To assess whether local IA r-PA, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months.;Secondary Objective: Secondary aim:To assess whether: 1. IA rt-PA improves the 7 day neurological deficit, as compared to IV rt-PA. 2. IA rt-PA is safe as compared to IV rt-PA, on the base of events reported within 7 days: symptomatic intracranial hemorrhages,fatal and non-fatal stroke, death from any cause, neurological deterioration.;Primary end point(s): survival free of disability (modified Rankin score of zero or 1) at 3 months. | — |
Countries
Italy
Outcome results
None listed