Randomized Evaluation of the effectiveness in terms of reduction of cerebral ischemia in patients undergoing carotid angioplasty load of different doses of clopidogrel (300vs600mg) and high-dose atorvastati

• Conditions: Patients with carotid stenosis undergoing angioplasty with stent implantation; MedDRA version: 14.1Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005330-18-IT
• Lead Sponsor: IVERSITA' CAMPUS BIOMEDICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

symptomatic or asymptomatic patients with reflected economic colordoppler angioTAC and carotid vascular disease of significant (> 70% diameter reduction according to the NASCET criteria or characteristics velocimetric)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Patients with recent ischemic stroke and / or presence of acute injury / subacute MRI of the brain.
- Patients with active bleeding or with contraindications taking dual antiplatelet therapy
- Patients with contraindications to statin therapy for history of severe liver disease, muscle diseases, or otherwise elevated baseline transaminase or CK
- Patients with contraindications to MR examination (pacemaker / claustrophobic).

Study & Design

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