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

NCT03715582 | Unknown Phase 3

• 1 other identifier: PSInCor-Trimetazidine
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Angina, Unstable

Outcome Measures

Primary Outcomes (1)

• peak values of troponin and CKMB after PCI

  comparing groups for peak values of troponin and CKMB after PCI.

  24 hours

Secondary Outcomes (10)

• peak values of CRP

  24 hours

• peak values of creatinine

  24 hours

• peak values of leukogram

  24 hours

• occurrence of sustained ventricular arrhythmia

  24 hours

• occurrence of cardiogenic shock,

  24 hours

Study Arms (2)

trimetazidine

EXPERIMENTAL

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

placebo

EXPERIMENTAL

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

Interventions

trimetazidine DRUG

Pills of masking drug - trimetazidine

trimetazidine

Placebo Oral Tablet DRUG

Pills of masking drug - placebo

Also known as: placebo

placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - HMFMUSP

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Angina, Unstable

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mucio Tavares, MD

  Unidade Clínica de Emergência

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Soeiro, MD

CONTACT

+55112661-5299; alexandre.soeiro@bol.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

BR (1)