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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 evaluation

Difference 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

Page last updated: August 23, 2015

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