EUCTR2016-004591-22-AT进行中（未招募）1 期
Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY-Trial) – a phase III Study - EMMY-Trial
Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology0 个研究点目标入组 476 人开始时间: 2017年2月7日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 476
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Myocardial infarction with evidence of significant myocardial necrosis defined as a rise in creatinine kinase >800 U/l and a troponin T- or I level >10x ULN. In addition at least 1 of the following criteria must be met:
- •- Symptoms of ischemia
- •- ECG changes indicative of new ischemia (new ST-T changes or new LBBB)
- •- Imaging evidence of new regional wall motion abnormality
- •2)18 – 80 years of age
- •3)Informed consent has to be given in written form.
- •4)eGFR > 45 ml/min/1.73m2
- •5)Blood pressure before first drug dosing >110 mmHg
- •6)Blood pressure before first drug dosing >70 mmHg
- •7)First intake of study medication =72h after myocardial infarction
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
排除标准
- •1)Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
- •2)Blood pH < 7,32
- •3)Known allergy to SGLT-2 inhibitors
- •4)Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors
- •5)>1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea
- •6)Females of child bearing potential without adequate contraceptive methods (i.e. sterilisation, intrauterine device, vasectimized partner; or medical history of hysterectomy)
- •7)Acute symptomatic urinary tract infection (UTI) or genital infection
- •8)Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2
- •inhibitor within the 4 weeks prior to the screening visit
研究者
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