Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- difference in NT-proBNP level
研究概览
简要总结
This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.
详细描述
DAPA was approved for HF patients, but there is no sufficient data about its efficacy on patients with AMI and if it can protect from the development of HF after AMI.
the investigators aim to investigate the effect of DAPA on patients who presented with AMI when administered as early as possible before pPCI and to be continued for three months after there.
the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ST-elevation myocardial infarction (STEMI).
- •STEMI was defined according to the Fourth Universal Definition of AMI.
- •18 - 80 years of age.
- •Diabetics or non-diabetics.
- •eGFR > 45 ml/min/1.73m
- •Blood pressure before first drug dosing >110/70 mmHg.
排除标准
- •Cardiogenic shock.
- •Hypoglycemia.
- •History of diabetic ketoacidosis.
- •Genital and urinary infections.
- •History of AMI.
- •Stent thrombosis.
- •Previous coronary artery bypass surgery.
- •Severe hepatic insufficiency.
- •Advanced cancer patients.
- •Blood pH < 7.
- •Known allergy to SGLT-2 inhibitors.
- •Hemodynamic instability.
- •Females of childbearing potential without adequate contraceptive methods.
- •Patients currently on or have received any SGLT-2 inhibitors.
研究组 & 干预措施
Dapagliflozin group
patients with MI will be treated with DAPA 10 mg once daily for three months.
干预措施: Dapagliflozin 10mg Tab (Drug)
Placebo group
patients with MI will be treated with a matching placebo once daily for three months.
干预措施: Placebo (Drug)
结局指标
主要结局
difference in NT-proBNP level
时间窗: 3 months
NT-proBNP level (pg/ml) for both groups
difference in infarct size
时间窗: 3 months
infarct size measurement (percentage) for both groups
次要结局
- Difference in eGFR(3 months)
研究者
Mohammad Hussien Tantawy Soliman
Principal Investigator
Tanta University