Clinical Study of The Early Application of Lvabradine For Acute Anterior Myocardial Infarction Patients After PCI With Early Heart Failure To Observe Cardiac Function And Prognosis

BackgroundThe incidence of acute myocardial infarction is increasing each year. Percutaneous coronary intervention has become highly preferred for patients with acute myocardial infarction because it not traumatic and improves heart function. However, the mortality and disability rates are still high. For the first time, we used ivabradine in patients with acute anterior myocardial infarction. We expect that this new method will enhance heart function and clinical prognosis because of heart rate control, decreases in heart preload and improvements in left ventricular end-diastolic volume.Method and analysisThis is a prospective, randomized, controlled, open-label, multicenter and optimally designed clinical trial. A total of 500 patients with acute anterior myocardial infarction after Percutaneous coronary intervention（PCI）with early heart failure will be enrolled. Eligible subjects will be randomized at a 1:1 ratio to take the standard drug treatment or receive the standard drug treatment plus ivabradine. The primary outcome measure is left ventricular end-diastolic volume. Left ventricular ejection fraction, adverse cardiac events, and the Canadian angina pectoris score will be evaluated as secondary endpoints. Blood biochemical testing will be used as the safety endpoints. Ethics and dissemination The clinical research will be carried out in strict accordance with the relevant Chinese laws and regulations, the Declaration of Helsinki, and the ethical and scientific principles stipulated by the Chinese GCP. All participants will provide informed consent. The personal information of patients will be kept confidential. Findings from the trial will be disseminated through peer-reviewed journals and scientific conferences.ClinicalTrials.govID:ChiCTR2000032731,Registered8May,2020 http://www.chictr.org.cn/showproj.aspx?proj=53275 Trial Statusversion number: Protocol version 1.0., approved9 May，2020Trial ongoingStudy execute time: From 1 September 2020 to 31 Octomber 2022Recruiting time: From 8 May 2020 to 31 December 2022