Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and Diabetes (Trimeta)

PROSPECTIVE ANALYSIS BETWEEN TRIMETAZIDINE Versus PLACEBO IN MYOCARDIAL INJURY AFTER PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH INSTANT ANGINA AND DIABETES MELLITUS

Introduction: Recent studies have suggested that trimetazidine may help reduce myocardial damage following percutaneous coronary intervention. However, the evaluation of the potential of this medication in the reduction of myocardial damage in patients with diabetes mellitus and unstable angina, in a prospective and randomized way, has not yet been described. Objective: The aim of this study was to evaluate the efficacy and safety of the use of trimetazidine versus placebo in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Myocardial damage will be measured by means of ultrasensitive Troponin dosages. Expected results: The use of trimetazidine reduces myocardial damage in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Angina, Unstable
• Intervention / Treatment: Drug: trimetazidine; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Recruiting
    • Instituto do Coração - HMFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult men and women aged> 18 years.
• Diagnosis of unstable angina with chest pain at least 2 hours after arrival at the emergency unit.
• Measurement of troponin less than the upper limit of the normality of the method.
• Indication of cardiac catheterization and need for percutaneous coronary intervention with uniarterial stent within 24 hours of admission.
• No known allergy to trimetazidine.
• Prior diagnosis of diabetes mellitus under specific treatment.
• ClCr> 30 mL / min.
• Signed consent form.

Exclusion Criteria:

• Pregnancy.
• Hemodynamic instability (pulmonary congestion / systolic blood pressure less than 90 mmHg).
• SCA with ST elevation or troponin elevation.
• Body mass index greater than 40 kg / m2.
• Use of oral anticoagulant.
• Orotracheal intubation.
• Left ventricular outflow tract obstruction.
• Allergy to iodinated contrast.
• Thoracic trauma in the last 30 days.
• Previous surgical myocardial revascularization.
• Presence of ventricular arrhythmias.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trimetazidine; The randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When the patient is randomized to the trimetazidine pill group, he / she will initiate the medication at 70 mg oral dose (2 tablets of Vastarel ® MR 35 mg single dose) 2 hours before the procedure.	Drug: trimetazidine; Pills of masking drug - trimetazidine
Experimental: placebo; The randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When randomized to the placebo oral tablets group, the patient will receive placebo (orally, 2 single dose tablets) also 2 hours prior to PCI.	Drug: Placebo Oral Tablet; Pills of masking drug - placebo; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak values of troponin and CKMB after PCI	comparing groups for peak values of troponin and CKMB after PCI.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak values of CRP	Comparison between groups for peak values of CRP after PCI.	24 hours
peak values of creatinine	Comparison between groups for peak values of creatinine after PCI.	24 hours
peak values of leukogram	Comparison between groups for peak values of leukogram after PCI.	24 hours
occurrence of sustained ventricular arrhythmia	Combined comparison between the occurrence of sustained ventricular arrhythmia	24 hours
occurrence of cardiogenic shock,	Combined comparison between the occurrence of cardiogenic shock,	24 hours
occurrence of cardiorespiratory arrest,	Combined comparison between the occurrence of cardiorespiratory arrest	24 hours
occurrence of worsening of renal function	Combined comparison between the occurrence of worsening of renal function (increase of 0.5 mg / dL in relation to admission creatinine or 25% above baseline)	24 hours
occurrence of need for reintervention	Combined comparison between the occurrence of need for reintervention	24 hours
occurrence of cerebrovascular accident	Combined comparison between the occurrence of cerebrovascular accident	24 hours
occurrence of death	Combined comparison between the occurrence of death	24 hours

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Chest Pain; Diabetes Mellitus; Angina Pectoris; Angina, Unstable; Vasodilator Agents; Trimetazidine
• Other Study ID Numbers: PSInCor-Trimetazidine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No