ECG changes and C-protein level variations during and after treatment with atorvastatin at different dosages in the secondary prevention of stroke. - ND

• Conditions: Stroke; MedDRA version: 9.1Level: LLTClassification code 10055221Term: Ischemic stroke

• Registration Number: EUCTR2009-010761-22-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-23
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age ranging from 18 and 90 years;
-Ischemic cerebral stroke with a neurologic syndrome related to a partial or complete infarct of posterior and/or anterior cerebral vascularization territory, following Bamford criteria. Included patients have to present one of the following clinical presentations:
1.at least one fo the following neurological deficits (depending to just one hemisphere impairment):
1.a.dysphasia or dyscalculia (for the impairment of the dominant hemisphere), visuo-spatial defict (i.e. neglect) for the impairment of the non-dominant hemisphere;
1.b.motor or sensory deficit involving at least two somatic districts, including face, arm and leg in the same side.
1.c.Homonymous hemianopsia or quadrantanopsia.
2.isolated superior function cerebral deficit.
3.motor or sensory deficit involving one arm or the face and the hand of the affected side.
4. vertebro-basilar syndrome.
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

hemorrhagic stroke
-Neurological deficit due to other causes instead of ischemia.
-participation in another research protocol.
-Blood, autoimmune or inflammatory cerebral diseases.
-impossibility to partecipate to follow-up clinical controls.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effects of the atorvastatine in the prognosis and in the frequency of new strokes during the follow-up period.;Secondary Objective: ND;Primary end point(s): ND