NCT02802644Unknown4 期
A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Effect of DiPeptidyl-Peptidase 4 Inhibitor on Vascular Healing After Biodegradable Polymer Based Sirolimus Eluting Stent Implantation in Diabetic Patients: OCT Study (DIAMOND-OCT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Neointimal coverage assessed by optical coherence tomography
研究概览
简要总结
This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-ST segement elevation acute coronary syndrome
排除标准
- •Left main disease
- •Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, sirolimus, siptagliptin and statin
- •Congestive heart failure (patients with LVEF <30% or cardiogenic shock)
- •Uncontrolled myocardial ischemia (repeated chest pain or dyspnea after revascularization)
- •Uncontrolled ventricular arrhythmia
- •History of malignancy with chemotherapy
- •Serious hematologic disease (e.g. CML, MDS)
- •Current infectious disease needs antibiotics therapy
- •Creatinine level >1.5 mg/dL or dependence on dialysis
- •Other severe concurrent illness (e.g. active infection, malignancy).
- •Life expectancy of less than one year
- •Pregnancy or women with potential childbearing
- •Type I DM
- •Treatment with insulin
- •History of pancreatitis
- •Who cannot read the informed consent form (e.g. illiteracy, foreigner)
研究组 & 干预措施
DPP-4 Inhibitor
Experimental
Any dose of Sitagliptin for 6 months with any other oral anti-diabetic medication
干预措施: Sitagliptin (Drug)
Non DPP-4 Inhibitor
Active Comparator
Oral anti-diabetic medication except DPP-4 inhibitor
干预措施: Non DPP-4 Inhibitor (Drug)
结局指标
主要结局
Neointimal coverage assessed by optical coherence tomography
时间窗: 6 months
次要结局
- Malapposition, neointimal thickness or any optical coherence tomographic finding(6 months)
- Biomarkers(6 months)
研究者
Sang-Wook Kim
MD, PhD
Chung-Ang University
研究点 (6)
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