Coronary Artery DiseasePhase 2/3NCT00482183
Comparison Between Pioglitazone and SES With type2 DM
A Phase 2/3 study testing Pioglitazone in people with Coronary Artery Disease and Type 2 Diabetes Mellitus, run by Showa University.
Trial summary
Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones effectively reduced restenosis and the risk of repeat target vessel revascularization. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Type 2 Diabetes Mellitus
- What is being tested?
- Pioglitazone
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jun 2007
- Phase
- Phase 2/3
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study.
Who cannot join
- spastic angina pectoris
- congestive heart failure
- hepatic dysfunction
- chronic renal disease
- recent stroke
- impaired glucose tolerance
Show all 11Show fewer
- insulin dependent diabetes mellitus
- familial hypercholesterolemia
- thyroid dysfunction
- adrenal dysfunction
- an intolerance of aspirin, ticlopidine, heparin, pioglitazone, stainless steel, or contrast material.
About this study
Official title: Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.
Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones effectively reduced restenosis and the risk of repeat target vessel revascularization. We conducted a study to compare the performance of a drug-eluting stent with that of a bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.
Read the detailed description
The study is a prospective cohort trial involving 38 type 2 diabetic patients referred for coronary stenting who were assigned to either the sirolimus-eluting stent group or the pioglitazone group. Quantitative coronary angiography will be performed at study entry and at six months follow-up to evaluate in-stent late luminal loss and the percentage of the luminal diameter and the rate of restenosis. We also analyze major adverse cardiac events at 12 months.
- Conditions
- Coronary Artery Disease, Type 2 Diabetes Mellitus
- Being tested
- Pioglitazone
- Keywords
- Bare metal stent, Major adverse cardiac events, Pioglitazone, Restenosis, Sirolimus eluting stent
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
Measured: Within 12minths after the procedure
Secondary outcomes (1)
Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startJul 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa University
- Sponsor type
- University, hospital or other
- Investigators
- Youichi Kobayashi, Professor, Study chair, Showa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482183
- Sponsor's protocol ID
- CCT-NAPN-16586
- Other IDs
- CCT-NAPN-16586
- Status last verified
- Jun 2007
- First submitted
- 4 Jun 2007
- Last updated
- 5 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Nishio K, Shigemitsu M, Kodama Y, Konno N, Katagiri T, Kobayashi Y. Comparison of bare metal stent with pioglitazone versus sirolimus-eluting stent for percutaneous coronary intervention in patients with Type 2 diabetes mellitus. Cardiovasc Revasc Med. 2009 Jan-Mar;10(1):5-11. doi: 10.1016/j.carrev.2008.06.004.
PubMed 19159848
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00482183
- Acronym / sponsor ID
- CCT-NAPN-16586
- Conditions
- Coronary Artery Disease, Type 2 Diabetes Mellitus
- Keywords
- Bare metal stent, Major adverse cardiac events, Pioglitazone, Restenosis, Sirolimus eluting stent
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Showa UniversityUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 5 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.
Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones effectively reduced restenosis and the risk of repeat target vessel revascularization. We conducted a study to compare the performance of a drug-eluting stent with that of a bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.
Detailed description
The study is a prospective cohort trial involving 38 type 2 diabetic patients referred for coronary stenting who were assigned to either the sirolimus-eluting stent group or the pioglitazone group. Quantitative coronary angiography will be performed at study entry and at six months follow-up to evaluate in-stent late luminal loss and the percentage of the luminal diameter and the rate of restenosis. We also analyze major adverse cardiac events at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study.
Key exclusion criteria (11 listed)
- spastic angina pectoris
- congestive heart failure
- hepatic dysfunction
- chronic renal disease
- recent stroke
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 |
|---|---|---|
| Pioglitazone | Drug | – |
Primary outcome
The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
Time frame: Within 12minths after the procedure
1 secondary outcome
Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.
Time frame: 6 months after procedure
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 5 Jun 2007.
- Derived from this study: PubMed 19159848Nishio K, Shigemitsu M, Kodama Y, Konno N, Katagiri T, Kobayashi Y. Comparison of bare metal stent with pioglitazone versus sirolimus-eluting stent for percutaneous coronary intervention in patients with Type 2 diabetes mellitus. Cardiovasc Revasc Med. 2009 Jan-Mar;10(1):5-11. doi: 10.1016/j.carrev.2008.06.004.
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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.
Youichi Kobayashi, Professor study chair
Showa University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pioglitazone in people with Coronary Artery Disease and Type 2 Diabetes Mellitus, run by Showa University.
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 1 inclusion and 11 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 5 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography. (time frame: Within 12minths after the procedure). 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 NCT00482183, 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 5 Jun 2007.