The Effect of Sacubitril/Valsartan Versus Valsartan on the Short-term Prognosis of Hypertensive Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of MACE events no.1 by phone calls and questionnaires
研究概览
简要总结
Studies have demonstrated that the early initiation of ACEI/ARB to patients with acute myocardial infarction is beneficial, especially in patients combined with reduced LVEF or mild-moderate heart failure. Therefore, ACEI/ARB is a traditional treatment for patients post-infarction. Recent clinical trials have demonstrated that Sacubitril/Valsartan is more beneficial than Ramipril to patients post-PCI.Besides, Sacubitril/Valsartan is also effective for essential hypertension.This study aims to assess the effect of Sacubitril/Valsartan on short-term prognosis in hypertensive patients with acute myocardial infarction compared against Valsartan.
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
- Triple (Participant, Investigator, 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
- •Diagnosed with new-onset MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days.
- •Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension.
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
排除标准
- •Patients with severe renal dysfunction. (GFR<60mmol/L).
- •Patients who have recently undergone immunosuppressive therapy.
- •Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan.
- •Patients who are hemodynamically unstable.
- •Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %).
- •Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
- •Any non-CV condition, such as active malignancy requiring treatment at the time of screening, or severe diseases with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
- •Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.
研究组 & 干预措施
Sacubitril/Valsartan
Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
干预措施: Sacubitril/Valsartan 49/51mg/Tab (Drug)
Valsartan
1 tablet of Valsartan every 24 hours for 6 months
干预措施: Valsartan 80mg/Tab (Drug)
结局指标
主要结局
Rate of MACE events no.1 by phone calls and questionnaires
时间窗: 6 months
To assess the rate of myocardial infarction in post-infarction patients during the study follow-up.
Rate of MACE events No.3 phone calls and questionnaires
时间窗: 6 months
To assess the rate of death from cardiovascular causes during the follow up time
Rate of MACE events No.2 by phone calls and questionnaires
时间窗: 6 months
To assess the rate of stroke in patients post-MI during the follow up period
次要结局
- Left ventricular ejection fraction(LVEF) by echocardiography(6 months)
- The rate of heart failure occurrence by following up in the clinic(6 months)
- Left ventricular end-diastolic volume(LVEDV) by echocardiography(6 months)
- Rate of post infarction angina by following up in the clinic(6 months)