The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

This study is ongoing, but not recruiting participants.

First Received: December 21, 2007 Last Updated: January 4, 2008 History of Changes

Sponsor:	Mayo Clinic
Collaborator:	Merck
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587717

Purpose

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

Condition	Intervention
Carotid Artery Disease	Drug: simvastatin Drug: placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans

Resource links provided by NLM:

MedlinePlus related topics: Carotid Artery Disease

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2002
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Two 80 mg pills simvastatin taken 24 hours prior to surgery	Drug: simvastatin Two 80 mg pills simvastatin taken 24 hours prior to surgery
2: Placebo Comparator Two 80 mg pills placebo are taken 24 hours prior to surgery	Drug: placebo take 2 80 mg pills placebo 24 hours prior to surgery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587717

Sponsors and Collaborators

Mayo Clinic

Merck

Investigators

Principal Investigator:

Amir Lerman, MD

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo clinic ( Amir Lerman, M.D. (principal investigator )
Study ID Numbers:	485-02, Merck #02005
Study First Received:	December 21, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00587717 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases
Carotid Artery Diseases

ClinicalTrials.gov processed this record on February 08, 2010