Clinical Efficacy of SGLT-2 Inhibitor After Stent Implantation in Patients With Coronary Heart Disease and Diabetes Mellitus：a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,424
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular and cerebrovascular events (MACCEs)
研究概览
简要总结
The study is to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus undergoing percutaneous coronary intervention.
详细描述
This is a single center, observational study designed to evaluate the efficacy of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention (PCI). 1424 subjects will be enrolled. All patients were divided into the SGLT-2 inhibitors group and other oral hypoglycemic agents group according to whether they were discharged with SGLT-2 inhibitors or not. The primary endpoint is adverse cardiovascular and cerebrovascular events (MACCE), composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and unplanned coronary revascularization at 12 months after the index PCI. The key secondary endpoints are changes in insulin resistance index and platelet reactivity at 3 months and change in glucose and lipid metabolism at 12 months after the index PCI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.
- •Patients were provided informed consent before the procedure.
排除标准
- •History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- •History of one or more severe hypoglycemic episode within 6 months before screening
- •Ongoing, inadequately controlled thyroid disorder.
- •History of hepatitis B surface antigen or hepatitis C antibody positive
- •Any history of or planned bariatric surgery.
- •Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication.
研究组 & 干预措施
Experimental
Subjects will be treated with SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) with or without conventional hypoglycemic drugs .
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Major adverse cardiovascular and cerebrovascular events (MACCEs)
时间窗: 12 months
MACCE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal myocardial stroke and unplanned coronary revascularization. Event rates are adjudicated by an endpoint committee based on the time to the first occurrence of MACCEs.
次要结局
- Changes of insulin resistance index(3 months)
- Changes of glycated hemoglobin (HbA1c)(12 months)
- Changes of platelet reactivity(3 months)
- Changes of fasting plasma glucose (FPG) level(12 months)
- Changes of plasma lipid parameters(12 months)
研究者
Xiaofan Wu
MD
Beijing Anzhen Hospital