Comparison of Bare Metal Stent With Pioglitazone Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study.
排除标准
- •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.
结局指标
主要结局
The primary angiographic end point is in-stent luminal late loss, as determined by quantitative angiography.
时间窗: Within 12minths after the procedure
次要结局
- Secondary end points include the percentage of in-stent stenosis of luminal diameter, the rate of restenosis.(6 months after procedure)