Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting
- Registration Number
- NCT01572623
- Lead Sponsor
- Campus Bio-Medico University
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- symptomatic and asymptomatic patients with finding of significant carotid stenosis
- patients with acute injuries to the baseline MRI of the brain,
- patients with active bleeding,
- contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Antiplatelet before carotid artery stenting Clopidogrel Clopidogrel 600 mg after carotid artery stenting Statin therapy before carotid artery stenting Atorvastatin Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.
- Primary Outcome Measures
Name Time Method Cerebral damage 30 days Incidence of stroke at 30 days (defined as a neurologic deficit lasting\> 24 hours with MRI evidence of cerebral ischemic injury) or transient ischemic attack (TIA);
- Evidence of new onset acute ischemic lesions on MRI-DWI brain after the procedure, even in the absence of specific neurological symptoms
- Secondary Outcome Measures
Name Time Method Bleeding complications 30 days Effect on the 30-day major and minor bleeding (according to the TIMI definition);
- Incidence of post-procedural vascular complications (pseudoaneurysm, AV fistula, hematoma\> 5 cm).
Trial Locations
- Locations (1)
Campus Bio Medico University of Rome
🇮🇹Rome, RM, Italy