Vericiguat in Patients With Acute Coronary Syndrome and Reduced Ejection Fraction: The EVE-ACSrEF Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- a composite of death from cardiovascular causes or first hospitalization for heart failure
研究概览
简要总结
Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection <45% between participants who take vericiguat regularly and those who donot.
详细描述
Vericiguat, a novel soluble guanylate cyclase stimulator, reduced the incidence of cardiovascular death or hospitalization for HF in a population of high-risk patients with heart failure with reduced ejection fraction （HFrEF ）who had recently been hospitalized or received intravenous diuretic therapy.Given the increasing incidence of patients with ACS and its challenges posing to life，investigators intend to conduct a prospective observational study. Investigators choose several meaningful endpoints including the time of cardiovascular death or heart failure（HF) hospitalization、inflammatory markers、the value of N-terminal pro-B-type natriuretic peptide(NT-proBNP)、results of echocardiogram and life quality score.By collecting these datas and work on a group of analysis ，investigators evaluate whether differences exsit in ACS patients with ejection <45% between participants who take vericiguat regularly and those who donot.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Provide written informed consent for the trial.
- •2.Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI]) or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]).
- •3.ejection fraction <45%.
- •4.Be male or female, aged greater than18 and less than 90 on the day of signing informed consent.
- •Exclusion Criteria.
- •1.SBP<100mmHg.
- •2.Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the trial.
- •3.Has severe hepatic insufficiency or renal insufficiency.
- •4.Has malignancy or other non-cardiac condition limiting life expectancy to <1 years.
排除标准
- 未提供
结局指标
主要结局
a composite of death from cardiovascular causes or first hospitalization for heart failure
时间窗: from baseline to one year
次要结局
- results of echocardiogram(from baseline to one year)
- the numerical value of NT-proBNP(from baseline to one year)
- life quality score(from baseline to one year)