The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

Mayo Clinic35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Carotid Artery Disease

Interventions

simvastatinDRUG

Two 80 mg pills simvastatin taken 24 hours prior to surgery

placeboDRUG

take 2 80 mg pills placebo 24 hours prior to surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 24 prior to surgery

Data from ClinicalTrials.gov

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