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The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

NCT ID: NCT00587717

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2006-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Carotid Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Two 80 mg pills simvastatin taken 24 hours prior to surgery

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

Two 80 mg pills simvastatin taken 24 hours prior to surgery

2

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

take 2 80 mg pills placebo 24 hours prior to surgery

Interventions

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simvastatin

Two 80 mg pills simvastatin taken 24 hours prior to surgery

Intervention Type DRUG

placebo

take 2 80 mg pills placebo 24 hours prior to surgery

Intervention Type DRUG

Other Intervention Names

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Zocor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo clinic

Principal Investigators

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Amir Lerman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

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485-02

Identifier Type: -

Identifier Source: org_study_id

Merck #02005

Identifier Type: -

Identifier Source: secondary_id