The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)

Overview

This study is a prospective randomized clinical trial and to compare the antiinflammatory effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy in carotid arteries of stable and unstable angina patients by PET/CT.

Full Title of Study: “Evaluation of the Effect of Atorvastatin and Pioglitazone in Carotid Atherosclerosis With the Use of 18Fluoride-Fludeoxyglucose(FDG) Positron Emission Tomography-computed Tomography (PET-CT)Imaging”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2012

Interventions

  • Drug: Atorvastatin 20mg
    • 20 mg QD for 3 months
  • Drug: Atorvastatin 20 mg + Pioglitazone 30 mg
    • atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months

Arms, Groups and Cohorts

  • Active Comparator: Atorvastatin 20 mg
    • After the subject take PET CT, he or she is randomized to either ” Atorvastatin 20 mg” group or ” Atorvastatin 20 mg+ Pioglitazone 30 mg”. The ” Atorvastatin 20 mg” group is to take atorvastatin 20 mg and take follow up PET CT in 3 months
  • Experimental: Atorvastatin 20 mg + Pioglitazone 30 mg
    • After the subject take PET CT, he or she is randomized to either ” Atorvastatin 20 mg” group or ” Atorvastatin 20 mg+ Pioglitazone 30 mg”. The ” Atorvastatin 20 mg + Pioglitazone 30 mg” group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months

Clinical Trial Outcome Measures

Primary Measures

  • Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
    • Time Frame: 3 months

Secondary Measures

  • Difference PET CT Parameters in 3 Months Compared to Initial Evaluation
    • Time Frame: 3 months
    • Change of Maximum Standardized Uptake Value (SUVmax),Mean Standardized Uptake Value (SUVmean)- no unit for this value
  • Difference of Laboratory Data Compared to Initial Evaluation
    • Time Frame: 3 months
    • Change of high sensitivity C-reactive protein (hsCRP, mg/dl) Change of low density lipoprotein cholesterol(mg/dl) Change of high density lipoprotein cholesterol(mg/dl) Change of triglyceride (mg/dl) Change of matrix metalloproteinase 9 (mcg/ml) Change of plasminogen activator inhibitor (PAI)-1 (ng/ml) Change of Homeostatic Model Assessment (HOMA) index (%)
  • Clinical Incidents
    • Time Frame: 3 months
    • Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization

Participating in This Clinical Trial

Inclusion Criteria

  • The subject who has undergone percutaneous coronary intervention due to coronary artery disease ( stable angina or unstable angina) – The subject described above who has atherosclerotic plaque in his/her carotid artery by carotid ultrasonography – The subject who or a legal representative agrees to the clinical trial and gives written permission to the IRB-approved form. Exclusion Criteria:

  • The subjets who have taken statins or thiazolidinedione with 4 weeks – Marked elevated liver enzyme ( more than 2.5 fold compared to reference range) – Renal insufficiency patients ( serum creatinine more than 2 mg/dl) – Congestive heart failure ( NYHA class 2-4) – Acue myocardial infarction – Unstable angina with ST segment deviation – Pregnancy – The subjects enrolled in another studies

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Catholic University of Korea
  • Collaborator
    • Jeil Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eun Ho Choo, Cardiovascular Center, Seoul St. Mary’s Hospital, – The Catholic University of Korea
  • Overall Official(s)
    • Kiyuk Chang, M.D., Principal Investigator, Department of Medicine, Seoul St. Mary’s hospital, The Catholic University of Korea, Colege of Medicine

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