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

NCT02826616 | Unknown DMC

• 1 other identifier: 1672sdd
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

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

Outcome Measures

Primary Outcomes (3)

• TIMI flow grade

  immediately post procedure

• Myocardial infarct size according to MR delayed enhancement scan

  3 to 5 days after PCI

• main cardiovascular events

  follow up in one year

Secondary Outcomes (1)

• change of the LVEF

  follow up in one year

Study Arms (2)

Trimetazidine group

EXPERIMENTAL

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

Drug: Trimetazidine

The control group

NO INTERVENTION

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

Interventions

Trimetazidine DRUG

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

Trimetazidine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (15)

• 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.

  PMID: 24969506 BACKGROUND

• 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.

  PMID: 20086077 BACKGROUND

• 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. doi: 10.1161/01.res.86.5.580.

  PMID: 10720420 BACKGROUND

• 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. doi: 10.1016/s0008-6363(00)00136-x.

  PMID: 10974217 BACKGROUND

• 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.

  PMID: 24809921 BACKGROUND

• 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. doi: 10.1136/hrt.2006.107524. Epub 2007 May 8.

  PMID: 17488771 BACKGROUND

• 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.

  PMID: 23982468 BACKGROUND

• 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. doi: 10.2165/00129784-200505040-00006.

  PMID: 15984909 BACKGROUND

• 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. doi: 10.1097/FJC.0b013e31814fa9cb.

  PMID: 18030070 BACKGROUND

• 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.

  PMID: 21134903 BACKGROUND

• Guler N, Eryonucu B, Gunes A, Guntekin 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. doi: 10.1023/a:1027376529708.

  PMID: 14696632 BACKGROUND

• 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.

  PMID: 18797405 BACKGROUND

• 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. doi: 10.2174/157016108785909788.

  PMID: 18855716 BACKGROUND

• 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.

  PMID: 22818072 BACKGROUND

• Qian G, A X, Jiang X, Jiang Z, Li T, Dong W, Guo J, Chen Y. Early Trimetazidine Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction Reduces Myocardial Infarction Size. Cardiovasc Drugs Ther. 2023 Jun;37(3):497-506. doi: 10.1007/s10557-021-07259-y. Epub 2021 Nov 12.

  PMID: 34767131 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Reperfusion Injury

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dai Yun Chen, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chinese People's Liberation Army General Hospital

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

CN (1)