The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)
Information source: The Catholic University of Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerosis; Coronary Artery Disease
Intervention: Atorvastatin 20mg (Drug); Atorvastatin 20 mg + Pioglitazone 30 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: The Catholic University of Korea Official(s) and/or principal investigator(s): Kiyuk Chang, M.D., Principal Investigator, Affiliation: Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine
Summary
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Difference of FDG uptake of atherosclerotic plaque in carotid artery by PET CT
Secondary outcome: Difference PET CT parameters in 3 months compared to initial evaluationDifference of laboratory data compared to initial evaluation Clinical incidents
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Cardiovascular center, Seoul St. Mary's hospital, Seoul 137-701, Korea, Republic of
Additional Information
Starting date: June 2011
Last updated: November 23, 2012
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