A Long-term, Randomized Study to Evaluate the Effects of Empagliflozin in Combination With Standard Hypoglycemic Therapy on Early and Long-term Results of Planned Percutaneous Coronary Interventions in Patients With Type 2 Diabetes.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- glomerular filtration rate(GFR)
研究概览
简要总结
Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes
详细描述
Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy.
Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed inform concent
- •stable coronary artery disease
- •planned percutaneous coronary intervention
- •diabetes mellitus
排除标准
- •previously performed coronary revascularization
- •glomerular filtration rate less than 45 ml/min
- •intolerance to empagliflozin
- •serum potassium more than 5/5 mmol/l
- •heart failure (NYHA III-IV)
- •congenital heart disease
- •acute coronary syndrome less than 3 months before enrollment
研究组 & 干预措施
Treatment group
The treatment group are patients with stable coronary artery disease before planned percutaneous coronary intervention. All of them will receive empagliflozin additionally to previously taken hypoglycemic treatment.
干预措施: Empagliflozin 10Mg Tab (Drug)
Control group
patients continue previously prescribed medication intake
干预措施: hypoglycemic therapy (Drug)
结局指标
主要结局
glomerular filtration rate(GFR)
时间窗: baseline-24 weeks
The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
HbA1C level
时间窗: baseline-24 weeks
The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
次要结局
未报告次要终点
研究者
Olga Barbarash
Principal
Research Institute for Complex Problems of Cardiovascular Diseases, Russia