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

Phase 4

Terminated

• Conditions: Atherosclerosis; Coronary Artery Disease
• Interventions: Drug: Atorvastatin 20mg; Drug: Atorvastatin 20 mg + Pioglitazone 30 mg

• Registration Number: NCT01341730
• Lead Sponsor: The Catholic University of Korea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-26
• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Results First Submitted: 2018-07-17
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Results First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin 20 mg	Atorvastatin 20mg	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
Atorvastatin 20 mg + Pioglitazone 30 mg	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

Primary Outcome Measures

Name	Time	Method
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT	3 months

Secondary Outcome Measures

Name	Time	Method
Difference PET CT Parameters in 3 Months Compared to Initial Evaluation	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	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	3 months	Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization

Trial Locations

Locations (1)

Cardiovascular center, Seoul St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of