NCT01341730

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
8 years until next milestone

Results Posted

Study results publicly available

August 6, 2020

Completed
Last Updated

August 6, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

April 20, 2011

Results QC Date

July 17, 2018

Last Update Submit

July 23, 2020

Conditions

AtherosclerosisCoronary Artery Disease

Keywords

AtherosclerosisPioglitazoneAtorvastatinPET CT

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (3)

  • Difference PET CT Parameters in 3 Months Compared to Initial Evaluation

    3 months

  • Difference of Laboratory Data Compared to Initial Evaluation

    3 months

  • Clinical Incidents

    3 months

Study Arms (2)

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

Drug: Atorvastatin 20mg

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

Drug: Atorvastatin 20 mg + Pioglitazone 30 mg

Interventions

Atorvastatin 20mgDRUG

20 mg QD for 3 months

Also known as: Lipitor 20mg
Atorvastatin 20 mg
Atorvastatin 20 mg + Pioglitazone 30 mgDRUG

atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months

Also known as: Lipitor 20mg plus Actos 30mg
Atorvastatin 20 mg + Pioglitazone 30 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular center, Seoul St. Mary's hospital

Seoul, 137-701, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29968431DERIVED

MeSH Terms

Conditions

AtherosclerosisCoronary Artery Disease

Interventions

AtorvastatinPioglitazone

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsThiazolidinedionesThiazolesSulfur CompoundsOrganic Chemicals

Results Point of Contact

Title
Dr. Eun Ho Choo
Organization
The Catholic University of Korea
cmcchu@catholic.ac.kr
82-10-8500-4569

Study Officials

  • Kiyuk Chang, M.D.

    Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Center, Seoul St. Mary's Hospital,

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 26, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

August 6, 2020

Results First Posted

August 6, 2020

Record last verified: 2020-07

Locations

KR(1)