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

The Catholic University of Korea

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease; Atherosclerosis

Treatments: Drug: Atorvastatin 20 mg + Pioglitazone 30 mg; Drug: Atorvastatin 20mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01341730

CUKCVC

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Atorvastatin 20 mg

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin 20mg

Atorvastatin 20 mg + Pioglitazone 30 mg

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin 20 mg + Pioglitazone 30 mg