The ImPact of Trimetazidine on MicrOcirculation After Stenting for Stable Coronary Artery Disease

NCT02107144 | Completed Phase 4 DMC

• 1 other identifier: ZEM - CARD - 002
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The study should enrol 50 patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention of single, de novo lesion of native coronary artery. Patients will be randomized to orally given trimetazidine on top of standard medical therapy for stable coronary artery disease versus standard therapy only. The randomization will begin 48 hrs before intervention. Index of microcirculatory resistance (IMR) will be measured by thermodilution method using coronary pressure and temperature wire before and after stent implantation. Echocardiography will be performed before intervention and within 30 minutes after intervention. Patients will be followed clinically for a period of one year.

Conditions

Coronary Artery Disease; Microcirculation; Vascular Resistance

Keywords

trimetazidine; microcirculation; stenting; pressure wire

Outcome Measures

Primary Outcomes (1)

• index of microcirculatory resistance

  Trimetazidine given on day 0 before elective percutaneous coronary intervention would decrease microvascular dysfunction by reducing index of microcirculatory resistance (IMR) measured by thermodilution method using coronary pressure and temperature wire on day 2 during PCI

  On day 2 during percutaneous coronary intervention

Secondary Outcomes (1)

• periprocedural myocardial necrosis

  on day 2 after PCI

Other Outcomes (1)

• change in 2D myocardial strain

  on day 2 30 minutes after completion of PCI procedure

Study Arms (2)

trimetazidin

EXPERIMENTAL

Patients, who are trimetazidine (TMZ) naïve, will be randomly assigned to receive trimetazidine plus previous medications (TMZ group) 48h before scheduled PCI- Paients that are TMZ naïve and randomized to TMZ group will be given oral loading of 70mg TMZ.

Drug: trimetazidine

Control

NO INTERVENTION

Patients, who are TMZ naïve, will be randomly assigned to receive just previous cardiac medication (Control group).

Interventions

trimetazidine DRUG

After being randomized to Trimetazidin and cardiac medication vs. only cardiac medication, patient will undergo scheduled PCI of single, new, native coronary artery lesion using balloon predilatation and subsequent stenting.

Also known as: Vastarel MR, Preductal MR, Trimetacor

trimetazidin

Eligibility Criteria

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

You may qualify if:

• presence of the stable angina or positive stress test
• Canadian Cardiovascular Society (CCS) class less than IV
• single, de novo, native coronary artery lesion
• diameter stenosis greater than 70%.

You may not qualify if:

• left ventricular systolic function (LVEF) less than 30%
• acute coronary syndrome
• history of previous myocardial infarction in the territory supplied by the treated coronary artery
• existence of the collateral circulation to another coronary artery supplied by the treated vessel
• chronic total occlusion
• significant bifurcation lesion
• previous surgical revascularization
• significant renal function impairment (GFR less than 60ml/min) allergy to any constituents of trimetazidin, aspirin and antiplatelet medications used after PCI, contrast agents
• contraindication to adenosine use
• Parkinson disease
• parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders

Sponsors & Collaborators

• Clinical Hospital Center Zemun: lead

Study Sites (1)

Institute for cardiovascular diseases Dedinje

Belgrade, 11040, Serbia

Location

Related Publications (4)

• Aussedat J, Ray A, Kay L, Verdys M, Harpey C, Rossi A. Improvement of long-term preservation of isolated arrested rat heart: beneficial effect of the antiischemic agent trimetazidine. J Cardiovasc Pharmacol. 1993 Jan;21(1):128-35. doi: 10.1097/00005344-199301000-00019.

  PMID: 7678667 BACKGROUND

• Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23.

  PMID: 12821539 BACKGROUND

• Ng MK, Yeung AC, Fearon WF. Invasive assessment of the coronary microcirculation: superior reproducibility and less hemodynamic dependence of index of microcirculatory resistance compared with coronary flow reserve. Circulation. 2006 May 2;113(17):2054-61. doi: 10.1161/CIRCULATIONAHA.105.603522. Epub 2006 Apr 24.

  PMID: 16636168 BACKGROUND

• Mangiacapra F, Peace AJ, Di Serafino L, Pyxaras SA, Bartunek J, Wyffels E, Heyndrickx GR, Wijns W, De Bruyne B, Barbato E. Intracoronary EnalaPrilat to Reduce MICROvascular Damage During Percutaneous Coronary Intervention (ProMicro) study. J Am Coll Cardiol. 2013 Feb 12;61(6):615-21. doi: 10.1016/j.jacc.2012.11.025. Epub 2013 Jan 2.

  PMID: 23290547 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Petar Otasevic, MD, PhD

  Institute for cardiovascular diseases Dedinje Belgrade, Serbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: interventional cardiologist

Study Record Dates

• First Submitted: March 29, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

SE (1)