Randomized,controlled,open study to evaluate the response to r-TPA therapy vs clinical standard therapy in patients affected by ictus at awakening coming in ER within 3 hours from symptoms compare. - ND
- Conditions
- patients affected by ictus at awakening coming in ER within 3 hours from symptoms compareMedDRA version: 9.1Level: LLTClassification code 10042244
- Registration Number
- EUCTR2010-019359-23-IT
- Lead Sponsor
- FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
patients aged between 18 and 80 years old; diagnosis of ischemic ictus with exclusion by TC of bleeding; neurologic dificit evaluable with NIHSS (= 3, = 25);no sponstaneous improvement; symptoms onset < 3 hours; etc.
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
patients allergic to one or more of the composes of the drug; patients affected by mild or severe renal impairment GFR/eGFR < 60mL/min; patients unable to perform RM; patients with severe claustrophobia.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the efficacy and tolerability of r-TPA therapy in patients with ictus at awakening;Secondary Objective: to find out the clinical and radiologic features to support the therapeutic response in patients with ictus at awakening;Primary end point(s): Functional indipendence at 3 months (point < equal to 2 to MRS)
- Secondary Outcome Measures
Name Time Method