The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carotid Artery Disease
Intervention: simvastatin (Drug); placebo (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Amir Lerman, MD, Principal Investigator, Affiliation: Mayo Clinic
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
Clinical Details
Official title: The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Mayo Clinic Clinical Trials
Starting date: September 2002
Ending date: January 2009
Last updated: January 4, 2008
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