The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587717
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : February 16, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Mayo Clinic

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

Condition or disease Intervention/treatment
Carotid Artery Disease Drug: simvastatin Drug: placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
Study Start Date : September 2002
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Two 80 mg pills simvastatin taken 24 hours prior to surgery
Drug: simvastatin
Two 80 mg pills simvastatin taken 24 hours prior to surgery
Other Name: Zocor
Placebo Comparator: 2
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00587717

Sponsors and Collaborators
Mayo Clinic
Merck Sharp & Dohme Corp.
Principal Investigator: Amir Lerman, MD Mayo Clinic

Additional Information:
Responsible Party: Amir Lerman, M.D. (principal investigator, Mayo clinic Identifier: NCT00587717     History of Changes
Other Study ID Numbers: 485-02
Merck #02005
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: February 16, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors