Comparison Between Pioglitazone and SES With type2 DM
Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.
1 other identifier
interventional
38
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 coronary-artery-disease
Started Jul 2003
Longer than P75 for phase_2 coronary-artery-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 4, 2007
CompletedFirst Posted
Study publicly available on registry
June 5, 2007
CompletedJune 5, 2007
June 1, 2007
June 4, 2007
June 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
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.
6 months after procedure
Interventions
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study.
You may not qualify if:
- spastic angina pectoris
- congestive heart failure
- hepatic dysfunction
- chronic renal disease
- recent stroke
- impaired glucose tolerance
- insulin dependent diabetes mellitus
- familial hypercholesterolemia
- thyroid dysfunction
- adrenal dysfunction
- an intolerance of aspirin, ticlopidine, heparin, pioglitazone, stainless steel, or contrast material.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Showa Universitylead
Related Publications (1)
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.
PMID: 19159848DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Youichi Kobayashi, Professor
Showa University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 4, 2007
First Posted
June 5, 2007
Study Start
July 1, 2003
Study Completion
June 1, 2007
Last Updated
June 5, 2007
Record last verified: 2007-06