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临床试验/NCT02826616
NCT02826616Unknown不适用

Chinese People's Liberation Army General Hospital

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
240
试验地点
1
主要终点
TIMI flow grade

研究概览

简要总结

Giving preoperative loading dose of 60mg of trimetazidine can safely and effectively reduce the PCI-related myocardial damage for the patients undergoing selective PCI. but the effect of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation myocardial infarction is not sure. this study aim to study the effect of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation myocardial infarction.

详细描述

Investigators will enroll 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between Januay 2017 and August 2017. STEMI was defined as typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T. We randomly assign eligible patients in a 1:1 ratio to either 60mg of trimetazidine or oral placebo befor PCI. Trimetazidine group will accept 20mg of trimetazidine for 12 months after PCI and active Comparator will be given placebo for 12 months after PCI.

Primary end point of the study was the area of viable myocardium coming from MR delayed enhancement scan and main cardiovascular events concluding recurrent myocardial infarction, cardiac death, recurrent angina, acute heart failure. Secondary end point of the study was the change of LVEF. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee. Each patient was contacted in every week after administration of the contrast, investigated main cardiovascular events (myocardial infarction,acute heart failure and death), and record any adverse events.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
  • patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

排除标准

  • The combined use of trimetazidine contraindications;
  • had cardiogenic shock,
  • had a history of myocardial infarction, stent thrombosis, or renal insufficiency;
  • had previously undergone coronary artery bypass surgery.

研究组 & 干预措施

Trimetazidine group

Experimental

Trimetazidine 60 mg 30 min before PCI and 20 mg for 12 months after surgery

干预措施: Trimetazidine (Drug)

结局指标

主要结局

TIMI flow grade

时间窗: immediately post procedure

main cardiovascular events

时间窗: follow up in one year

Myocardial infarct size according to MR delayed enhancement scan

时间窗: 3 to 5 days after PCI

次要结局

  • change of the LVEF(follow up in one year)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qian geng

Chinese People's Liberation Army General Hospital

Chinese PLA General Hospital

研究点 (1)

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