Atherosclerosis, Coronary Artery Disease
Conditions
Keywords
Atherosclerosis, Pioglitazone, Atorvastatin, PET CT
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.
Interventions
DRUGAtorvastatin 20mg
20 mg QD for 3 months
DRUGAtorvastatin 20 mg + Pioglitazone 30 mg
atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
Sponsors
Jeil Pharmaceutical Co., Ltd.
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Participant flow
Recruitment details
The study was terminated prematurely due to slow enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 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
Atorvastatin 20mg: 20 mg QD for 3 months | 16 |
| 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
Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Atorvastatin 20 mg | Atorvastatin 20 mg + Pioglitazone 30 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 62.9 years STANDARD_DEVIATION 11 | 63.4 years STANDARD_DEVIATION 10.5 | 63 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 17 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin 20 mg | Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT | -0.06 standardized uptake value (SUV) | Standard Deviation 0.04 |
| Atorvastatin 20 mg + Pioglitazone 30 mg | Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT | -0.10 standardized uptake value (SUV) | Standard Deviation 0.07 |
Secondary
Clinical Incidents
Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization
Time frame: 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 (%)
Time frame: 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
Time frame: 3 months
Population: Data were not collected