NCT03208465已完成4 期
Empagliflozin Versus Sitagliptin Therapy for Improvement of Myocardial Perfusion Reserve in Diabetic Patients With Coronary Artery disease_ELITE Trial
CHEOL WHAN LEE, M.D., Ph.D1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent change in global myocardial perfusion reserve (MPR) index
研究概览
简要总结
This trial evaluates the effects of Empagliflozin versus Sitagliptin, in addition to standard of care, on global myocardial perfusion reserve using dynamic single-photon emission computed tomography (SPECT) images.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 19 years of age
- •Type 2 diabetes mellitus
- •Stable coronary artery disease
- •Global myocardial perfusion reserve (MPR) index < 2.5
- •The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Contraindications to empagliflozin, Sitagliptin
- •DPP4 inhibitors or Sodium-glucose cotransporter-2(SGLT2) inhibitors within the previous 4 weeks
- •Insulin requiring diabetes
- •Poor glucose control (HbA1C>10 %)
- •Acute coronary syndrome
- •Stent placement within the previous 6 months
- •Previous coronary artery bypass graft surgery within the previous 6 months
- •Planned revascularization within 6 months
- •Heart failure requiring loop diuretics
- •Severe left ventricular hypertrophy (left ventricular septal wall thickness > 13mm)
- •Significant renal disease manifested by creatinine clearance of < 30 ml/min)
- •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase or Aspartate Aminotransferase > 3 times upper limit of normal)
- •Radiopaque material implanted in the chest wall (metal, silicone, etc.)
- •Contraindication to adenosine stress test
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •Patient's pregnant or breast-feeding or child-bearing potential
- •Expected life expectancy < 1 year
- •Unwillingness or inability to comply with the procedures described in this protocol
研究组 & 干预措施
Patients with Empagliflozin
Experimental
干预措施: Empagliflozin (Drug)
Patients with Sitagliptin
Active Comparator
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Percent change in global myocardial perfusion reserve (MPR) index
时间窗: 6 months
Percent change in global myocardial perfusion reserve (MPR) index defined as (global MPR index at 6 months - global MPR index at baseline)/(global MPR index at baseline)x100. MPR index=stress myocardial flow/rest myocardial flow
次要结局
- Percent change in regional MPR index(6 months)
- Absolute change in global MPR index(6 months)
- Absolute change in regional MPR index(6 months)
研究者
CHEOL WHAN LEE, M.D., Ph.D
professor
Asan Medical Center
研究点 (1)
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