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

NCT ID: NCT02826616

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trimetazidine group

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

Group Type EXPERIMENTAL

Trimetazidine

Intervention Type DRUG

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

The control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trimetazidine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qian geng

Chinese People's Liberation Army General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dai Yun Chen, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 20086077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10720420 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 24809921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17488771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23982468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15984909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18030070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21134903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14696632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18797405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18855716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22818072 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34767131 (View on PubMed)

Other Identifiers

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1672sdd

Identifier Type: -

Identifier Source: org_study_id

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