A Multi-center, Prospective Randomized Controlled Trial on the Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- LV remodeling index on CMR
研究概览
简要总结
The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with ST-elevation myocardial infarction (STEMI) than enalapril.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 - 75 years old
- •First-time ST-segment elevation myocardial infarction based on the newest ESC guidelines
- •Timely primary percutaneous coronary intervention within 12 hours from onset
- •Written informed consent acquired
排除标准
- •Known history of or persistent clinical chronic heart failure prior to randomization
- •Previous use of ARNI, or intolerance or contraindications to study drugs including ARNI or ACEI
- •History of significant chronic coronary obstruction and adverse ventricular remodeling
- •History of any cardiomyopathy, valvular heart disease, congenital heart disease, stent or CABG, or planned open-heart surgery within 3 months
- •History of hepatic impairment or history of cirrhosis with evidence of portal hypertension
- •History of chronic renal dysfunction, or eGFR < 30 ml/min/1.73 m2
- •History of malignancy and with a life span less than one year
- •Patients with a known history of angioedema related to previous ACEIs/ARB therapy.
- •With contraindication to MRI examination (pacemaker and claustrophobia) or cannot finish breath-holding when lying on the examination bed
- •Pregnancy or nursing women
研究组 & 干预措施
ARNI-Sacubitril-Valsartan
patients randomized to angiotensin receptor neprilysin inhibitor (ARNI) group will receive 2 doses of angiotensin receptor blocker (ARB) to ensure a minimum 36-hour washout period prior to initiation of ARNI therapy, and then be started with the first dose or sacubitril-valsartan.
干预措施: Sacubitril-Valsartan (Drug)
ARNI-Sacubitril-Valsartan
patients randomized to angiotensin receptor neprilysin inhibitor (ARNI) group will receive 2 doses of angiotensin receptor blocker (ARB) to ensure a minimum 36-hour washout period prior to initiation of ARNI therapy, and then be started with the first dose or sacubitril-valsartan.
干预措施: Valsartan (Drug)
ACEI-Enalapril
patients randomized to angiotensin-converting enzyme inhibitor (ACEI) group will directly start with the first dose of enalapril
干预措施: Enalapril (Drug)
结局指标
主要结局
LV remodeling index on CMR
时间窗: 6 months
change of the indexed LV mass (Δ LVmassi) from baseline to 6-month follow-up on CMR
次要结局
- myocardial fibrosis(6 months)
- Time to the first occurrence of a composite endpoint of adverse clinical events(up to approximately 60 months)
- left ventricular (LV) ejection fraction(6 months)
- global peak LV longitudinal strain(6 months)