The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

NCT00587717 | Completed

• 2 other identifiers: 485-02Merck #02005
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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

Conditions

Carotid Artery Disease

Outcome Measures

Primary Outcomes (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.

  24 prior to surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Two 80 mg pills simvastatin taken 24 hours prior to surgery

Drug: simvastatin

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

simvastatin DRUG

Two 80 mg pills simvastatin taken 24 hours prior to surgery

Also known as: Zocor

1

placebo DRUG

take 2 80 mg pills placebo 24 hours prior to surgery

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Amir Lerman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: September 1, 2002
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: December 12, 2023

Record last verified: 2023-12