Carotid Stenosis
Conditions
Keywords
Therapeutic strategies for carotid artery stenting
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.
Interventions
DRUGClopidogrel
Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting
DRUGAtorvastatin
Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* symptomatic and asymptomatic patients with finding of significant carotid stenosis
Exclusion criteria
* patients with acute injuries to the baseline MRI of the brain, * patients with active bleeding, * contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Italy
Contacts
Primary ContactGiuseppe Patti, MD
Outcome results
None listed