NCT05045274Unknown不适用
The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Echocardiographic parameter
研究概览
简要总结
300 STIMI patients with LV systolic dysfunction will be divided into two equal groups (Group I (Study arm, n=150); will receive dapagliflozin plus conventional therapy and group (II) Control arm (n=150); will receive conventional therapy only to detect an improvement in the LVEF by ≥ 5
详细描述
300 STIMI patients with LV systolic dysfunction will be randomly divided into two equal groups (Group I (Study arm, n=150); will receive
- Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
- Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
- Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
- Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI.
Group (II) Control arm (n=150); will receive
- Reperfusion therapy: as in study arm
- Anti-ischemic treatment: as in study arm.
- Anti-failure treatment: as in study arm. LV echocardiographic analysis for both groups at baseline and 3 month follow up by 2D Echocardiography to assess: LVEF by simpson method Diastolic function LV diameter and volume. LA volume index. LV mass index. Severity of MR.
Laboratory investigation substudy analysis:
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1st time STEMI within 24 hours undergoing PPCI. (Chest pain > 30 minutes and ST segment elevation in more than one lead, include the definition of MI with a reference: Third universal definition of MI. (published at ESC Clinical Practice Guidelines 2012).
- •LVEF less than 50%.
- •eGFR ≥20 mL/min/1.73 m2.
排除标准
- •Patients less than 18 years old.
- •T1D (Type I diabetes mellitus).
- •Hemodynamically unstable.
- •Cardiogenic shock (clinical syndrome of tissue hypoperfusion resulting from cardiac dysfunction).
- •History of chronic symptomatic HF with a prior hHF within last year
- •Patients on dialysis.
- •Serious hypersensitivity to dapagliflozin (eg, anaphylaxis, angioedema).
- •Pregnant or lactating women.
- •Sever hepatic impairment.
研究组 & 干预措施
dapagliflozin
Active Comparator
(a) Dapagliflozin 10 mg once daily within 24 hours after PPCI for 3 month
干预措施: Dapagliflozin 10Mg Tab (Drug)
conventional therapy
Placebo Comparator
- Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
- Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
- Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
干预措施: Placebo (Drug)
结局指标
主要结局
Echocardiographic parameter
时间窗: 3 month follow up
The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography
次要结局
- Laboratory investigations.(3 month follow up)
- Changes in diastolic function(3 month follow up)
- Changes in LV mass index.(3 month follow up)
- CV death and rehospitalization of HF(3 month follow up)
- Individual component at composite end points.(3 month follow up)
- ACS(3 month follow up)
- Changes in LV remodeling(3 month follow up)
- Changes in LA volume index(3 month follow up)
研究者
George William Agban
Principle investigator
Assiut University
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