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

This study has been completed.
Sponsor:
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Eun Ho Choo, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01341730
First received: April 20, 2011
Last updated: November 23, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Atherosclerosis
Coronary Artery Disease
Drug: Atorvastatin 20mg
Drug: Atorvastatin 20 mg + Pioglitazone 30 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Difference of FDG uptake of atherosclerotic plaque in carotid artery by PET CT [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference PET CT parameters in 3 months compared to initial evaluation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization


Enrollment: 40
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lipitor 20mg plus Actos 30mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341730

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Eun Ho Choo, Cardiovascular Center, Seoul St. Mary's Hospital,, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01341730     History of Changes
Other Study ID Numbers: CUKCVC
Study First Received: April 20, 2011
Last Updated: November 23, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
Atherosclerosis
Pioglitazone
Atorvastatin
PET CT

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Arteriosclerosis
Carotid Artery Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atorvastatin
Pioglitazone
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014