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临床试验/IRCT20190412043247N2
IRCT20190412043247N2尚未招募4 期

The assessment of Empagliflozin Effects in diabetic patients with coronary artery disease: The EMPA-CARD Randomized Clinical Trial

Zanjan University of Medical Sciences0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
40 years 至 75 years(—)
性别
All

入选标准

  • Age between 40-75 year-old
  • HbA1c between 6.5 to 9
  • Diabetes mellitus type 2
  • Under fix continues anti-diabetic treatment for at least 3 month
  • BMI less than 40
  • Fixed Diet and physical activity
  • Resting heart rate between 60 to 100 b/min
  • Use of Aspirin 80 mg/Daily for at least 3 month prior to the beginning of study
  • Glomerular filtration rate (GFR)>45
  • Documented known Coronary Artery Disease

排除标准

  • Heart Failure (NYHA class 3-4), Ejection Fraction <40%
  • History of allergic reaction to SGLT2 inhibitors Drugs
  • History of SGLT2 inhibitor Drugs usage
  • Gastrointestinal malabsorbtion disease
  • History of CABG, ACS, TIA,CVA or PCI during past 3 month
  • History or presence of malignancy
  • Anemia (Hb<10 g/dl)
  • History of heart or lung transplant
  • Major psychiatric disorders
  • History of DKA
  • Elevated liver enzymes >3 times upper normal limit
  • Use of drugs prolonging QT interval
  • Presence of Arrhythmia
  • Electrolyte disorders
  • Patients with Pace Maker
  • Use of anti-coagulant or anti-platelet drugs for at least 3 months prior to the sampling
  • Consumption of alcohol, Anti inflammatory drugs (except Aspirin) or Anti oxidant supplement
  • Platelet count <100000/µl
  • History of infection during 1 one month before sampling

研究者

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