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

Chinese People's Liberation Army General Hospital

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02826616
Enrollment
240
Registered
2016-07-11
Start date
2016-07-31
Completion date
Unknown
Last updated
2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Trimetazidine, ST-segment elevation myocardial, Reperfusion injury, Percutaneous coronary intervention

Brief 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.

Detailed 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.

Interventions

DRUGTrimetazidine

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

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

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.

Design outcomes

Primary

MeasureTime frame
TIMI flow gradeimmediately post procedure
Myocardial infarct size according to MR delayed enhancement scan3 to 5 days after PCI
main cardiovascular eventsfollow up in one year

Secondary

MeasureTime frame
change of the LVEFfollow up in one year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026