The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

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

Completed

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Key information

Conditions

Carotid Artery Disease Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

Two 80 mg pills simvastatin taken 24 hours prior to surgery

Other names: Zocor

Placebo

Drug

take 2 80 mg pills placebo 24 hours prior to surgery

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2006
First posted: Jan 7, 2008
Registry last updated: Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed