Efficacy Study of Nicorandil on Neointima After Coronary Drug-eluting Stent Implantation in Patients With Diabetic Mellitus
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Neointimal thickness (in μm)
研究概览
简要总结
The investigators aim to investigate the effect of oral nicorandil on neointima after coronary drug-eluting stent implantation in patients with diabetic mellitus.
详细描述
In the era of bare metal stent (BMS), the restenosis rate was about 25%. The introduction of drug-eluting stent (DES) reduces restenosis rate to 4%-10%. Neointimal hyperplasia and restenosis remain to be problems after DES implantation. Besides, DES causes an increase in uncovered struts, late stent thrombosis, neoatherosclerosis, and heterogeneous neointima. Diabetes mellitus (DM) results in increased risk for atherosclerosis, in-stent restenosis, neoatherosclerosis and late-stent thrombosis. Nicorandil, a hybrid of adenosine triphosphate-sensitive potassium (K-ATP) channel opener and nitrates, has been shown to reduce target vessel revascularization after stent implantation, target lesion revascularization after rotational atherectomy, and restenosis in patients undergoing percutaneous coronary intervention (PCI). Intracoronary optical coherence tomography(OCT) has emerged as a high-resolution imaging method for analysis of neointima that grows over the stent. We aim to examine the effect of nicorandil on the neointima after coronary DES implantation in patients with unstable angina and DM.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unstable angina with diabetes mellitus and is not given glibenclamide
- •have clinical indication of percutaneous coronary intervention
- •de novo severe stenosis in a native coronary artery
- •lesion suitable for stent and optical coherence tomography examination
- •reference vessel size between 2.5 and 4.0mm
- •drug-eluting stent implantation only
排除标准
- •acute myocardial infarction within 2 weeks before percutaneous coronary intervention
- •contraindications to treatment with nicorandil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
- •bypass restenosis
- •PCI history
- •hypotension
- •intolerance of platelet inhibitors and statins
- •impaired liver function
- •renal insufficiency requiring hemodialysis
- •pregnancy
- •connective tissue disease
- •life expectancy ≤ 12 months
- •left main coronary artery disease
- •bypass graft lesion and lesions unsuitable for OCT
- •unwillingness or inability to provide informed consent
研究组 & 干预措施
Nicorandil group
Drug: Nicorandil (Chugai Pharmaceutical Co, Japan). The first dose is given 8h before selective percutaneous coronary intervention, 10mg, oral. After the percutaneous coronary intervention, nicorandil is given for 30 days, 5mg each time, 3 times daily oral.
干预措施: Nicorandil (Drug)
Control group
Drug: Nicorandil placebo (Sihuan Pharmaceutical Co, China). The first dose is given 8h before selective percutaneous coronary intervention, 2 tablets, oral. After the percutaneous coronary intervention, placebo is given for 30 days, 1 tablet each time, 3 times daily oral.
干预措施: nicorandil placebo (Drug)
结局指标
主要结局
Neointimal thickness (in μm)
时间窗: 9 month
Neointimal thickness is defined as the distance between the stent strut and lumen surface.
Neointimal area
时间窗: 9 month
Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.
次要结局
- percent of uncovered stent struts(9 month)
- rate of restenosis (in %)(9 month)
- characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima)(9 month)
- number of major adverse cardiovascular events(9 month)
- number of uncovered stent struts(9 month)
- number of in-stent neoatherosclerosis(9 month)
- angiographic late lumen loss (in mm)(9 month)
研究者
Zhang Ying Qian
M.D.
Chinese PLA General Hospital