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

NCT02107144 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2023-06-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Clinical Hospital Center Zemun

    lead OTHER

Principal Investigators

  • Petar Otasevic, MD, PhD · Institute for cardiovascular diseases Dedinje Belgrade, Serbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Serbia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02107144 on ClinicalTrials.gov