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

NCT ID: NCT03715582

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

trimetazidine

Intervention Type: DRUG

Pills of masking drug - trimetazidine

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.

Group Type: EXPERIMENTAL

Placebo Oral Tablet

Intervention Type: DRUG

Pills of masking drug - placebo

Interventions

trimetazidine

Pills of masking drug - trimetazidine

Intervention Type: DRUG

Placebo Oral Tablet

Pills of masking drug - placebo

Intervention Type: DRUG

Other Intervention Names

placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mucio Tavares, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Clínica de Emergência

Locations

Instituto do Coração - HMFMUSP

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Alexandre Soeiro, MD

Role: CONTACT

alexandre.soeiro@bol.com.br

+55112661-5299

Facility Contacts

Alexandre Soeiro, MD

Role: primary

alexandre.soeiro@bol.com.br

5511-2661-5299

Other Identifiers

PSInCor-Trimetazidine

Identifier Type: -

Identifier Source: org_study_id