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

Coronary Artery Disease Clinical Trial

— PIONEER  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01341730
• Other study ID #: CUKCVC
• Status: Terminated
• Phase: Phase 4
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2020
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Cardiovascular center, Seoul St. Mary's hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT		3 months
Secondary	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	3 months
Secondary	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 (%)	3 months
Secondary	Clinical Incidents	Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization	3 months