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

Phase 4TerminatedNCT01341730

The Catholic University of Korea41 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atherosclerosis Coronary Artery Disease

Interventions

Atorvastatin 20mgDRUG

20 mg QD for 3 months

Atorvastatin 20 mg + Pioglitazone 30 mgDRUG

atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Cardiovascular center, Seoul St. Mary's hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT

Time frame: 3 months

Secondary Outcomes

Difference PET CT Parameters in 3 Months Compared to Initial Evaluation

Change of Maximum Standardized Uptake Value (SUVmax),Mean Standardized Uptake Value (SUVmean)- no unit for this value

Time frame: 3 months

Difference of Laboratory Data Compared to Initial Evaluation

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 (%)

Time frame: 3 months

Clinical Incidents

Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization

Time frame: 3 months

Data from ClinicalTrials.gov

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