Intravenous glycoprotein IIbIIIa inhibitor (Tirofiban) combined with low dose of intra-arterial Urokinase for the endovascolar treatment of patients with acute major ischemic stroke - Tirofiban-Urokinasi 2007
- Conditions
- patients with major ischemic stroke not suitable for other authorized treatment for riperfusion of the ischemic areaMedDRA version: 6.1Level: PTClassification code 10057613
- Registration Number
- EUCTR2007-001996-13-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SENESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?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
?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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br><br>- Ricanalization rate at the end and at 24 hours after the procedure <br><br>- Modified Ranking Scale Score at 7 days, at discharge and after 3 months <br><br>- 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.
- Secondary Outcome Measures
Name Time Method