The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
This study has been completed.
Sponsor:
Mayo Clinic
Collaborator:
Merck
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587717
First received: December 21, 2007
Last updated: February 14, 2011
Last verified: February 2011
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Purpose
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 | Intervention |
|---|---|
|
Carotid Artery Disease |
Drug: simvastatin Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | September 2002 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Amir Lerman, M.D. (principal investigator, Mayo clinic |
| ClinicalTrials.gov Identifier: | NCT00587717 History of Changes |
| Other Study ID Numbers: | 485-02, Merck #02005 |
| Study First Received: | December 21, 2007 |
| Last Updated: | February 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Simvastatin Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013