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

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01341730
• Collaborator: Jeil Pharmaceutical Co., Ltd. (Industry)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Coronary Artery Disease	Drug: Atorvastatin 20mg; Drug: Atorvastatin 20 mg + Pioglitazone 30 mg	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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	Drug: Atorvastatin 20mg; 20 mg QD for 3 months; Other Names: Lipitor 20mg
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	Drug: Atorvastatin 20 mg + Pioglitazone 30 mg; atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months; Other Names: Lipitor 20mg plus Actos 30mg

Outcome Measures

Primary Outcome Measures

1. Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT [3 months]

Secondary Outcome Measures

1. 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

2. 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 (%)

3. Clinical Incidents [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular center, Seoul St. Mary's hospital	Seoul		Korea, Republic of	137-701

Sponsors and Collaborators

• The Catholic University of Korea
• Jeil Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Kiyuk Chang, M.D., Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eun Ho Choo, Cardiovascular Center, Seoul St. Mary's Hospital,, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT01341730
• Other Study ID Numbers: CUKCVC
• First Posted: Apr 26, 2011
• Last Update Posted: Aug 6, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Eun Ho Choo, Cardiovascular Center, Seoul St. Mary's Hospital,, The Catholic University of Korea: Atherosclerosis; Pioglitazone; Atorvastatin; PET CT
• Additional relevant MeSH terms: Carotid Artery Diseases; Coronary Artery Disease; Atherosclerosis; Pioglitazone; Atorvastatin

Study Results

Participant Flow

Recruitment Details	The study was terminated prematurely due to slow enrollment.

Arm/Group Title	Atorvastatin 20 mg	Atorvastatin 20 mg + Pioglitazone 30 mg
Arm/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 Atorvastatin 20mg: 20 mg QD for 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 Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
Period Title: Overall Study
STARTED	20	21
COMPLETED	16	17
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Atorvastatin 20 mg	Atorvastatin 20 mg + Pioglitazone 30 mg	Total
Arm/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 Atorvastatin 20mg: 20 mg QD for 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 Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months	Total of all reporting groups
Overall Participants	16	17	33
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 56.3%	10 58.8%	19 57.6%
>=65 years	7 43.8%	7 41.2%	14 42.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (11.0)	63.4 (10.5)	63 (10.7)
Sex: Female, Male (Count of Participants)
Female	8 50%	5 29.4%	13 39.4%
Male	8 50%	12 70.6%	20 60.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	16 100%	17 100%	33 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
South Korea	16 100%	17 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atorvastatin 20 mg	Atorvastatin 20 mg + Pioglitazone 30 mg
Arm/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 Atorvastatin 20mg: 20 mg QD for 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 Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
Measure Participants	16	17
Mean (Standard Deviation) [standardized uptake value (SUV)]	-0.06 (0.04)	-0.10 (0.07)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Atorvastatin 20 mg	Atorvastatin 20 mg + Pioglitazone 30 mg
Arm/Group Description	Data were not collected	Data were not collected
Measure Participants	0	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Atorvastatin 20 mg		Atorvastatin 20 mg + Pioglitazone 30 mg
Arm/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 Atorvastatin 20mg: 20 mg QD for 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 Atorvastatin 20 mg + Pioglitazone 30 mg: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
All Cause Mortality
	Atorvastatin 20 mg		Atorvastatin 20 mg + Pioglitazone 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Atorvastatin 20 mg		Atorvastatin 20 mg + Pioglitazone 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Atorvastatin 20 mg		Atorvastatin 20 mg + Pioglitazone 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.