AtherosclerosisPhase 4PIONEERNCT01341730
The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)
A Phase 4 study testing Atorvastatin 20mg and Atorvastatin 20 mg + Pioglitazone 30 mg in people with Atherosclerosis and Coronary Artery Disease, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease
- What is being tested?
- Atorvastatin 20mg and Atorvastatin 20 mg + Pioglitazone 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cardiovascular center, Seoul St. Mary's hospital
Seoul, 137-701
About this study
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
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.
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Being tested
- Atorvastatin 20mg, Atorvastatin 20 mg + Pioglitazone 30 mg
- Keywords
- Atherosclerosis, Pioglitazone, Atorvastatin, PET CT
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
Also called Lipitor 20mg
20 mg QD for 3 months
Atorvastatin 20 mg + Pioglitazone 30 mgDrug
Also called Lipitor 20mg plus Actos 30mg
atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Atorvastatin 20 mg + Pioglitazone 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
Measured: 3 months
Secondary outcomes (3)
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
Measured: 3 months
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 (%)
Measured: 3 months
Clinical Incidents
Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Eun Ho Choo, The Catholic University of Korea
- Investigators
- Kiyuk Chang, M.D., Principal investigator, Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341730
- Sponsor's protocol ID
- CUKCVC
- Acronym
- PIONEER
- Status last verified
- Jul 2020
- First submitted
- 20 Apr 2011
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29968431
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01341730
- Acronym / sponsor ID
- PIONEER / CUKCVC
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Keywords
- Atherosclerosis, Pioglitazone, Atorvastatin, PET CT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Apr 2011 (estimated)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 20 mg | Active comparator | Drug: Atorvastatin 20mgAfter 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 20 mg + Pioglitazone 30 mg | Experimental | Drug: Atorvastatin 20 mg + Pioglitazone 30 mgAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 20mgAlso: Lipitor 20mg20 mg QD for 3 months | Drug | Atorvastatin 20 mg |
| Atorvastatin 20 mg + Pioglitazone 30 mgAlso: Lipitor 20mg plus Actos 30mgatorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months | Drug | Atorvastatin 20 mg + Pioglitazone 30 mg |
Primary outcome
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
Time frame: 3 months
3 secondary outcomes
Difference PET CT Parameters in 3 Months Compared to Initial Evaluation
Time frame: 3 months
Difference of Laboratory Data Compared to Initial Evaluation
Time frame: 3 months
Clinical Incidents
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29968431Choo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyuk Chang, M.D. principal investigator
Department of Medicine, Seoul St. Mary's hospital, The Catholic University of Korea, Colege of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin 20mg and Atorvastatin 20 mg + Pioglitazone 30 mg in people with Atherosclerosis and Coronary Artery Disease, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01341730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.