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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Atorvastatin 20 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" group is to take atorvastatin 20 mg and take follow up PET CT in 3 months

Group Type ACTIVE_COMPARATOR

Atorvastatin 20mg

Intervention Type DRUG

20 mg QD for 3 months

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

Group Type EXPERIMENTAL

Atorvastatin 20 mg + Pioglitazone 30 mg

Intervention Type DRUG

atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months

Interventions

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Atorvastatin 20mg

20 mg QD for 3 months

Intervention Type DRUG

Atorvastatin 20 mg + Pioglitazone 30 mg

atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months

Intervention Type DRUG

Other Intervention Names

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Lipitor 20mg Lipitor 20mg plus Actos 30mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No