Trial Outcomes & Findings for The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT) (NCT NCT01341730)

NCT ID: NCT01341730

Last Updated: 2020-08-06

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 41 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-08-06

Participant Flow

The study was terminated prematurely due to slow enrollment.

Participant milestones

Measure	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	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
Overall Study STARTED	20	21
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Atorvastatin 20 mg n=16 Participants 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	Atorvastatin 20 mg + Pioglitazone 30 mg n=17 Participants 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 n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	62.9 years STANDARD_DEVIATION 11.0 • n=5 Participants	63.4 years STANDARD_DEVIATION 10.5 • n=7 Participants	63 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Korea	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	Atorvastatin 20 mg n=16 Participants 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	Atorvastatin 20 mg + Pioglitazone 30 mg n=17 Participants 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
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	-0.10 standardized uptake value (SUV) Standard Deviation 0.07

SECONDARY outcome

Timeframe: 3 months

Population: Data were not collected

Change of Maximum Standardized Uptake Value (SUVmax),Mean Standardized Uptake Value (SUVmean)- no unit for this value

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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 (%)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome data not reported

Adverse Events

Atorvastatin 20 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atorvastatin 20 mg + Pioglitazone 30 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eun Ho Choo

The Catholic University of Korea

Phone: 82-10-8500-4569

Email: cmcchu@catholic.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place