Diabetes MellitusPhase 4NCT00494559
The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers
A Phase 4 study testing Pioglitazone in people with Diabetes Mellitus and Coronary Artery Stenosis, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Coronary Artery Stenosis
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years and above
- Gender eligible for study: both
- Diabetic patients either previously diagnosed or newly found diabetes.
- Fasting blood glucose ≥ 126 mg/dl or PP2 blood glucose ≥ 200 mg/dl for newly found diabetes.
- Patients with significant de novo coronary artery disease (diameter stenosis > 70%) requiring stent implantation (angina pectoris and/or exercise-induced ischemia).
- Patients with informed consent.
Who cannot join
- Acute ST-segment elevation myocardial infarction (MI)
- CTO lesions
- Left main lesions
- Diabetic patients with the use of thiazolidinediones within 3 months
- Previous history of PCI or bypass surgery
- Patients with any contraindications to the treatment of thiazolidinediones
Show all 12Show fewer
- Pregnant or lactating patients
- Chronic alcohol or drug abuse
- Hepatic dysfunction
- Renal dysfunction
- Heart failure (EF < 50%)
- Expected life expectancy of < 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Pioglitazone on Neointima Volume and Inflammatory Markers in Diabetic Patients
People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Several studies have been reported that diabetes increased the risk of cardiovascular mortality in both men and women. With the introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later months have reduced dramatically in several studies. However, even with DESs, diabetic patients showed increased rates of restenosis and late loss index compared with nondiabetic patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era of DESs, no study has demonstrated the clinical and angiographic outcomes in diabetic patients after zotarolimus-eluting stent implantation by using intravascular ultrasound (IVUS).
Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The effect of pioglitazone on neointima volume and inflammatory markers has not been compared in prospective manner after zotarolimus-eluting stent implantation. The purpose of this prospective, randomized, single blinded trial is to compare the effect of pioglitazone on inflammatory markers and neointima volume by using IVUS in diabetic patients.
Read the detailed description
With the introduction of the DES, the angiographic rates of restenosis have decreased dramatically but less prominently in diabetic patients. Even in the era of DES, diabetes remains a significant predictor of coronary restenosis especially in cases of small baseline and post PCI vessel size, longer stent length, current smokers, and high level of CRP. Restenosis remains a main clinical and angiographic concern after DES implantation especially in diabetic patients. Diabetes has been known as a major risk factor for in-stent restenosis after DES implantation.
- Primary end point: Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).
- Secondary end point: Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
- Conditions
- Diabetes Mellitus, Coronary Artery Stenosis
- Being tested
- Pioglitazone, Placebo
- Keywords
- Type 2 Diabetes, Pioglitazone, restenosis
- Medical subject headings
- Diabetes Mellitus, Coronary Stenosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Actos 15mg once a day before breakfast
PlaceboDrug
Placebo drug with the same appearance as actos
| Study group | Role | What they receive |
|---|---|---|
| Actos | Experimental | Actos group: pioglitazone 15mg or 30mg Receives: Drug: Pioglitazone |
| Placebo | Placebo comparator | Placebo group: placebo without active medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).
Measured: 8 month follow-up
Secondary outcomes (1)
Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
Measured: 8 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Jun Hong, Korea University Anam Hospital
- Investigators
- Soon Jun Hong, MD, PhD, Principal investigator, Korea University Anam HospitalSang Yup Lim, MD, PhD, Study director, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494559
- Sponsor's protocol ID
- PRAISE
- Status last verified
- Feb 2016
- First submitted
- 28 Jun 2007
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Pioglitazone on Neointima Volume and Inflammatory Markers in Diabetic Patients
- ClinicalTrials.gov ID
- NCT00494559
- Acronym / sponsor ID
- PRAISE
- Conditions
- Diabetes Mellitus, Coronary Artery Stenosis
- Keywords
- Type 2 Diabetes, Pioglitazone, restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Several studies have been reported that diabetes increased the risk of cardiovascular mortality in both men and women. With the introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later months have reduced dramatically in several studies. However, even with DESs, diabetic patients showed increased rates of restenosis and late loss index compared with nondiabetic patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era of DESs, no study has demonstrated the clinical and angiographic outcomes in diabetic patients after zotarolimus-eluting stent implantation by using intravascular ultrasound (IVUS).
Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The effect of pioglitazone on neointima volume and inflammatory markers has not been compared in prospective manner after zotarolimus-eluting stent implantation. The purpose of this prospective, randomized, single blinded trial is to compare the effect of pioglitazone on inflammatory markers and neointima volume by using IVUS in diabetic patients.
Detailed description
With the introduction of the DES, the angiographic rates of restenosis have decreased dramatically but less prominently in diabetic patients. Even in the era of DES, diabetes remains a significant predictor of coronary restenosis especially in cases of small baseline and post PCI vessel size, longer stent length, current smokers, and high level of CRP. Restenosis remains a main clinical and angiographic concern after DES implantation especially in diabetic patients. Diabetes has been known as a major risk factor for in-stent restenosis after DES implantation.
- Primary end point: Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).
- Secondary end point: Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actos | Experimental | Drug: PioglitazoneActos group: pioglitazone 15mg or 30mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group: placebo without active medication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 years and above
- Gender eligible for study: both
- Diabetic patients either previously diagnosed or newly found diabetes.
- Fasting blood glucose ≥ 126 mg/dl or PP2 blood glucose ≥ 200 mg/dl for newly found diabetes.
- Patients with significant de novo coronary artery disease (diameter stenosis > 70%) requiring stent implantation (angina pectoris and/or exercise-induced ischemia).
Key exclusion criteria (12 listed)
- Acute ST-segment elevation myocardial infarction (MI)
- CTO lesions
- Left main lesions
- Diabetic patients with the use of thiazolidinediones within 3 months
- Previous history of PCI or bypass surgery
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 |
|---|---|---|
| PioglitazoneAlso: ActosActos 15mg once a day before breakfast | Drug | Actos |
| PlaceboPlacebo drug with the same appearance as actos | Drug | Placebo |
Primary outcome
Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS).
Time frame: 8 month follow-up
1 secondary outcome
Comparison of pioglitazone and placebo on the changes in the levels of inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
Time frame: 8 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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.
Soon Jun Hong, MD, PhD principal investigator
Korea University Anam Hospital
Sang Yup Lim, MD, PhD study director
Korea University Anam Hospital
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 Pioglitazone in people with Diabetes Mellitus and Coronary Artery Stenosis, run by Korea University Anam Hospital 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 25 Feb 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of pioglitazone and placebo on 8 months follow-up neointima volume by intravascular ultrasound (IVUS). (time frame: 8 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2016.