Carotid Artery Disease
Conditions
Brief summary
This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy
Interventions
DRUGsimvastatin
Two 80 mg pills simvastatin taken 24 hours prior to surgery
DRUGplacebo
take 2 80 mg pills placebo 24 hours prior to surgery
Sponsors
Merck Sharp & Dohme LLC
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing carotid endarterectomy * No previously known side effects of statins * Patients who will sign an informed consent * Age \> 18 years old * No signs of current infection
Exclusion criteria
* Patient hypersensitive to any component of this medication * Patients with acute liver disease (AST\> normal value) * Patients with chronic liver disease (history of Hepatitis B or C) * Patients with renal failure (creatinine \> 3.0) * Patients with unexplained muscle pains and aches * Patients with rheumatoid arthritis * Patients with Lupus * Current cancer treatment * Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone * Pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure. | 24 prior to surgery |
Outcome results
None listed