patients with major ischemic stroke not suitable for other authorized treatment for riperfusion of the ischemic area MedDRA version: 6.1 Level: PT Classification code 10057613
Conditions
Interventions
Trade Name: AGGRASTAT*IV FL 50ML 0,25MG/ML
Product Name: Tirofiban
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tirofiban
Current Sponsor code: Tirofiban-Urokinasi 2
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? patients with neurological deficits due to an ischemic stroke excluded from the intravenous recombinant tissue plasminogen activator (rtPA) therapy because getting out from the 3 hours time window treatment, or for the poor neurological grade (NHISS>25) ? stroke in progress with rapid deterioration of consciousness ? a precisely defined, witnessed and non fluctuating onset of stroke less than 6 hours, for anterior circulation occlusions ? ischemic time up to 12 hours from the onset of stroke from vertebro-basilar occlusions even with fluctuating neurological deficits ? evidence of a major cerebral artery-ies occlusion-s on angio-TC or transcranial doppler or angiogram ? exclusion of cerebral or subarachnoid hemorrhage, subtle early ischemic signs, cerebral edema and old large ischemic lesions on admission TC. Are the trial subjects under 18? yes 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: ? slight neurological deficit or with rapid improvement. ? NHISS  than 25 in less than 3 hours onset of ischemic stroke. ? blood pressure  200/120 resistant to therapy. ? life expectation < 1 year ? recent major surgery < 15 days ? pregnancy or 10 days post-partum ? gastrointestinal, urinary or respiratory tract hemorrhage < 15 days ? known defect of clotting or platelet funcion ? platelets <100.000 ? acute pancreatitis ? cirrhosis ? cerebral or subarachnoid hemorrhage on admission TC. ? presence of a large old ischemic lesion on TC ? presence of a cerebral tumor or vascular malformation ? presence of subtle early ischemic signs ? patency of the major cerebral arteries (angiogram or TC) ? cortical embolism (angiogram)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Modification of the NIHSS score  7 points at 24 hours, at 7 days after treatment and at discharge.;Secondary Objective: -Incidence of symptomatic intracerebral hemorrhage (increase of the NIHSS score 4) - Ricanalization rate at the end and at 24 hours after the procedure - Modified Ranking Scale Score at 7 days, at discharge and after 3 months - Mortality rate at hospital and at 3 months after the procedure.;Primary end point(s): ? Modification of the NIHSS score  7 points at 24 hours, at 7 days after treatment and at discharge. | — |
Countries
Italy
Outcome results
None listed