The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

December 11, 2023 updated by: Mayo Clinic

The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 prior to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Amir Lerman, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimated)

January 7, 2008

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 485-02
  • Merck #02005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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