跳至主要内容
临床试验/KCT0004802
KCT0004802终止未知

Effects of dapaglifloziN Therapy on myocardial perfusion Reserve in prediabetic patients with stable coronarY artery disease

Asan Medical Center0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
终止
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
18(Year) 至 0No Limit(—)
性别
All

入选标准

  • 1) Men or women at least 18 years of age
  • 2)Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4% )(3)
  • 3)Stable coronary artery disease
  • 4)Global myocardial perfusion reserve (MPR) index < 2.0
  • 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

  • 1) Contraindications to dapapagliflozin
  • 2) Significant renal disease manifested by creatinine clearance of(eGFR<30 ml/min/1.73m2
  • 3) Unstable or rapidly progressing renal disease
  • 4) Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
  • 5) Stent placement, or coronary artery bypass graft surgery within the previous 6 months
  • 6) Planned revascularization within 6 months
  • 7) Significant disease (diameter stenosis >70% by coronary CT angiography) in major epicardial coronary arteries
  • 8) Heart failure requiring loop diuretics
  • 9) Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
  • 10) Contraindication to adenosine stress test*
  • 11) Current treatment for the active cancer
  • 12) Women of child bearing potential who are not willing to use a medically accepted method of contraception. Patient’s pregnancy confirmed by positive pregnancy test, or breast-feeding.
  • 13) Expected life expectancy < 1 year
  • 14) Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests which, in the judgment of the investigator, would preclude safe completion of the study.
  • 15) Unwillingness or inability to comply with the procedures described in this protocol.

研究者

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