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

Cardiovascular Diseases Clinical Trial

Official title:

Chinese People's Liberation Army General Hospital

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02826616
• Other study ID #: 1672sdd
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 5, 2016
• Last updated: July 5, 2016
• Start date: July 2016

Study information

• Verified date: July 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
China	Chinese People's Liberation Army General Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (14)

Banach M, Rysz J, Goch A, Mikhailidis DP, Rosano GM. The role of trimetazidine after acute myocardial infarction. Curr Vasc Pharmacol. 2008 Oct;6(4):282-91. Review. — View Citation

Belardinelli R, Lacalaprice F, Faccenda E, Volpe L. Trimetazidine potentiates the effects of exercise training in patients with ischemic cardiomyopathy referred for cardiac rehabilitation. Eur J Cardiovasc Prev Rehabil. 2008 Oct;15(5):533-40. doi: 10.1097/HJR.0b013e328304feec. — View Citation

Bonello L, Sbragia P, Amabile N, Com O, Pierre SV, Levy S, Paganelli F. Protective effect of an acute oral loading dose of trimetazidine on myocardial injury following percutaneous coronary intervention. Heart. 2007 Jun;93(6):703-7. Epub 2007 May 8. — View Citation

Chen J, Zhou S, Jin J, Tian F, Han Y, Wang J, Liu J, Chen Y. Chronic treatment with trimetazidine after discharge reduces the incidence of restenosis in patients who received coronary stent implantation: a 1-year prospective follow-up study. Int J Cardiol. 2014 Jul 1;174(3):634-9. doi: 10.1016/j.ijcard.2014.04.168. Epub 2014 Apr 21. — View Citation

Di Napoli P, Di Giovanni P, Gaeta MA, Taccardi AA, Barsotti A. Trimetazidine and reduction in mortality and hospitalization in patients with ischemic dilated cardiomyopathy: a post hoc analysis of the Villa Pini d'Abruzzo Trimetazidine Trial. J Cardiovasc Pharmacol. 2007 Nov;50(5):585-9. — View Citation

El Banani H, Bernard M, Baetz D, Cabanes E, Cozzone P, Lucien A, Feuvray D. Changes in intracellular sodium and pH during ischaemia-reperfusion are attenuated by trimetazidine. Comparison between low- and zero-flow ischaemia. Cardiovasc Res. 2000 Sep;47(4):688-96. — View Citation

El-Kady T, El-Sabban K, Gabaly M, Sabry A, Abdel-Hady S. Effects of trimetazidine on myocardial perfusion and the contractile response of chronically dysfunctional myocardium in ischemic cardiomyopathy: a 24-month study. Am J Cardiovasc Drugs. 2005;5(4):271-8. — View Citation

Gao D, Ning N, Niu X, Hao G, Meng Z. Trimetazidine: a meta-analysis of randomised controlled trials in heart failure. Heart. 2011 Feb;97(4):278-86. doi: 10.1136/hrt.2010.208751. Epub 2010 Dec 5. Review. — View Citation

Güler N, Eryonucu B, Günes A, Güntekin U, Tuncer M, Ozbek H. Effects of trimetazidine on submaximal exercise test in patients with acute myocardial infarction. Cardiovasc Drugs Ther. 2003 Jul;17(4):371-4. — View Citation

Jogiya R, Kozerke S, Morton G, De Silva K, Redwood S, Perera D, Nagel E, Plein S. Validation of dynamic 3-dimensional whole heart magnetic resonance myocardial perfusion imaging against fractional flow reserve for the detection of significant coronary artery disease. J Am Coll Cardiol. 2012 Aug 21;60(8):756-65. doi: 10.1016/j.jacc.2012.02.075. Epub 2012 Jul 18. — View Citation

Kantor PF, Lucien A, Kozak R, Lopaschuk GD. The antianginal drug trimetazidine shifts cardiac energy metabolism from fatty acid oxidation to glucose oxidation by inhibiting mitochondrial long-chain 3-ketoacyl coenzyme A thiolase. Circ Res. 2000 Mar 17;86(5):580-8. — View Citation

Kim JS, Kim CH, Chun KJ, Kim JH, Park YH, Kim J, Choi JH, Lee SH, Kim EJ, Yu DG, Ahn EY, Jeong MH. Effects of trimetazidine in patients with acute myocardial infarction: data from the Korean Acute Myocardial Infarction Registry. Clin Res Cardiol. 2013 Dec;102(12):915-22. doi: 10.1007/s00392-013-0611-0. Epub 2013 Aug 28. — View Citation

Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23. — View Citation

Lopaschuk GD, Ussher JR, Folmes CD, Jaswal JS, Stanley WC. Myocardial fatty acid metabolism in health and disease. Physiol Rev. 2010 Jan;90(1):207-58. doi: 10.1152/physrev.00015.2009. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI flow grade		immediately post procedure	Yes
Primary	Myocardial infarct size according to MR delayed enhancement scan		3 to 5 days after PCI	Yes
Primary	main cardiovascular events		follow up in one year	Yes
Secondary	change of the LVEF		follow up in one year	Yes