- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01341730
The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT) (PIONEER)
July 23, 2020 updated by: Eun Ho Choo, The Catholic University of Korea
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 137-701
- Cardiovascular center, Seoul St. Mary's hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
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20 mg QD for 3 months
Other Names:
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Experimental: 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
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atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference PET CT Parameters in 3 Months Compared to Initial Evaluation
Time Frame: 3 months
|
Change of Maximum Standardized Uptake Value (SUVmax),Mean Standardized Uptake Value (SUVmean)- no unit for this value
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3 months
|
Difference of Laboratory Data Compared to Initial Evaluation
Time Frame: 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 (%)
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3 months
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Clinical Incidents
Time Frame: 3 months
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Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kiyuk Chang, M.D., Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 20, 2011
First Submitted That Met QC Criteria
April 25, 2011
First Posted (Estimate)
April 26, 2011
Study Record Updates
Last Update Posted (Actual)
August 6, 2020
Last Update Submitted That Met QC Criteria
July 23, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Carotid Artery Diseases
- Atherosclerosis
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Pioglitazone
Other Study ID Numbers
- CUKCVC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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