The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

Mayo Clinic

Status: Completed

Conditions: Carotid Artery Disease

Treatments: Drug: simvastatin; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00587717

485-02

Merck #02005

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Two 80 mg pills simvastatin taken 24 hours prior to surgery

Treatment:

Drug: simvastatin

2

Placebo Comparator group

Description:

Two 80 mg pills placebo are taken 24 hours prior to surgery

Treatment:

Drug: placebo