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

Primary Purpose

Atherosclerosis, Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin 20mg
Atorvastatin 20 mg + Pioglitazone 30 mg
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Atherosclerosis, Pioglitazone, Atorvastatin, PET CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiovascular center, Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Atorvastatin 20 mg

Atorvastatin 20 mg + Pioglitazone 30 mg

Arm 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

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

Outcomes

Primary Outcome Measures

Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT

Secondary Outcome Measures

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
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 (%)
Clinical Incidents
Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization

Full Information

First Posted
April 20, 2011
Last Updated
July 23, 2020
Sponsor
The Catholic University of Korea
Collaborators
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01341730
Brief Title
The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)
Acronym
PIONEER
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Coronary Artery Disease
Keywords
Atherosclerosis, Pioglitazone, Atorvastatin, PET CT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin 20 mg
Arm Type
Active Comparator
Arm 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
Arm Title
Atorvastatin 20 mg + Pioglitazone 30 mg
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20mg
Other Intervention Name(s)
Lipitor 20mg
Intervention Description
20 mg QD for 3 months
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20 mg + Pioglitazone 30 mg
Other Intervention Name(s)
Lipitor 20mg plus Actos 30mg
Intervention Description
atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
Primary Outcome Measure Information:
Title
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Difference PET CT Parameters in 3 Months Compared to Initial Evaluation
Description
Change of Maximum Standardized Uptake Value (SUVmax),Mean Standardized Uptake Value (SUVmean)- no unit for this value
Time Frame
3 months
Title
Difference of Laboratory Data Compared to Initial Evaluation
Description
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
Title
Clinical Incidents
Description
Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyuk Chang, M.D.
Organizational Affiliation
Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular center, Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29968431
Citation
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.
Results Reference
derived

Learn more about this trial

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

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