Effect of Trimetazidine During the Primary PCI on Cardiac Function in Patients With ST-elevation Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT02826616|
Recruitment Status : Unknown
Verified July 2016 by Qian geng, Chinese PLA General Hospital.
Recruitment status was: Enrolling by invitation
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Drug: Trimetazidine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Chinese People's Liberation Army General Hospital|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||August 2017|
Experimental: Trimetazidine group
Trimetazidine 60 mg 30 min before PCI and 20 mg for 12 months after surgery
Trimetazidine 60 mg 30min before PCI and 20 mg for 12 months after surgery
No Intervention: The control group
placebo 60 mg 30 min before PCI and 20 mg for 12 months after surgery
- TIMI flow grade [ Time Frame: immediately post procedure ]
- Myocardial infarct size according to MR delayed enhancement scan [ Time Frame: 3 to 5 days after PCI ]
- main cardiovascular events [ Time Frame: follow up in one year ]
- change of the LVEF [ Time Frame: follow up in one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826616
|Chinese People's Liberation Army General Hospital|
|Peking, Beijing, China, 100853|
|Study Chair:||Dai Yun Chen, MD||Chinese PLA General Hospital|