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

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ClinicalTrials.gov Identifier: NCT02107144
Recruitment Status : Unknown
Verified March 2016 by Ivan Ilic, Clinical Hospital Center Zemun.
Recruitment status was:  Recruiting
First Posted : April 8, 2014
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ivan Ilic, Clinical Hospital Center Zemun

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Microcirculation Vascular Resistance Drug: trimetazidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Study to Assess the Effect of Trimetazidine on Index of Microcirculatory Resistance (IMR), Measured by Coronary Pressure and Temperature Wire, in Patients With Stable Coronary Artery Disease
Study Start Date : April 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: trimetazidin
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
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.
Other Names:
  • Vastarel MR
  • Preductal MR
  • Trimetacor

No Intervention: Control
Patients, who are TMZ naïve, will be randomly assigned to receive just previous cardiac medication (Control group).



Primary Outcome Measures :
  1. index of microcirculatory resistance [ Time Frame: On day 2 during percutaneous coronary intervention ]
    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


Secondary Outcome Measures :
  1. periprocedural myocardial necrosis [ Time Frame: on day 2 after PCI ]
    Periprocedural myocardial necrosis will be measured by collecting blood samples for Troponin I, CK and CK-MB at 6, 12 and 24 h after the procedure.


Other Outcome Measures:
  1. change in 2D myocardial strain [ Time Frame: on day 2 30 minutes after completion of PCI procedure ]
    Comprehensive echocardiogram with 2D-strain analysis will be done before and immediately after PCI procedure to correlate change in IMR with possible change in 2D strain after PCI



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107144


Locations
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Serbia
Clinical Hospital Center Zemun Recruiting
Belgrade, Serbia, 11080
Contact: Ivan Ilic, MD    +381641374455    ivan1ilic@yahoo.com   
Contact: Gojko Obradovic, MD    +381641391139    drgojko@yahoo.com   
Sub-Investigator: Miliovoje Cerovic, MD         
Principal Investigator: Aleksandar N Neskovic, MD, PhD         
Sub-Investigator: Srdjan Kafedzic, MD         
Sponsors and Collaborators
Clinical Hospital Center Zemun
Investigators
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Study Director: Aleksandar N Neskovic, MD, PhD Clinical Hospital Center Zemun

Publications:
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Responsible Party: Ivan Ilic, interventional cardiologist, Clinical Hospital Center Zemun
ClinicalTrials.gov Identifier: NCT02107144    
Other Study ID Numbers: ZEM - CARD - 002
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Keywords provided by Ivan Ilic, Clinical Hospital Center Zemun:
trimetazidine
microcirculation
stenting
pressure wire
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Trimetazidine
Vasodilator Agents