Effect of Trimetazidine During the Primary PCI on Cardiac Function in Patients With ST-elevation Myocardial Infarction

Last updated: July 5, 2016
Sponsor: Chinese PLA General Hospital
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Angina

Vascular Diseases

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT02826616
1672sdd
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clearST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, andelevated blood levels of troponin T

  • patients were scheduled to undergo diagnostic cardiac angiography or percutaneouscoronary interventions

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 240
Study Start date:
July 01, 2016
Estimated Completion Date:

Study Description

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.

Connect with a study center

  • Chinese People's Liberation Army General Hospital

    Peking, Beijing 100853
    China

    Site Not Available

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