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| Name | Class |
|---|---|
| Jeil Pharmaceutical Co., Ltd. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 20 mg | Active Comparator | 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 |
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| Atorvastatin 20 mg + Pioglitazone 30 mg | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20mg | Drug | 20 mg QD for 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Difference of Laboratory Data Compared to Initial Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kiyuk Chang, M.D. | Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular center, Seoul St. Mary's hospital | Seoul | 137-701 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29968431 | Derived | Choo EH, Han EJ, Kim CJ, Kim SH, O JH, Chang K, Seung KB. Effect of Pioglitazone in Combination with Moderate Dose Statin on Atherosclerotic Inflammation: Randomized Controlled Clinical Trial Using Serial FDG-PET/CT. Korean Circ J. 2018 Jul;48(7):591-601. doi: 10.4070/kcj.2017.0029. |
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The study was terminated prematurely due to slow enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Atorvastatin 20 mg + Pioglitazone 30 mg | Drug | atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months |
|
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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 |
| Clinical Incidents | Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization | 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 Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months |
| COMPLETED |
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| NOT COMPLETED |
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Four patients from each group withdrew the consent after enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 3 months |
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| 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 | Data were not collected | Posted | 3 months |
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| 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 (%) | Not Posted | 3 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Incidents | Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization | Not Posted | 3 months | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 16 | 0 | 16 | ||
| EG001 | 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 | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eun Ho Choo | The Catholic University of Korea | 82-10-8500-4569 | cmcchu@catholic.ac.kr |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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