The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587717
First received: December 21, 2007
Last updated: February 14, 2011
Last verified: February 2011
  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:
  • Zocor
  • Simvastatin
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587717

Sponsors and Collaborators
Mayo Clinic
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Amir Lerman, MD Mayo Clinic
  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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014