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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus; Angina, Unstable

Treatments: Drug: trimetazidine; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03715582

PSInCor-Trimetazidine

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

trimetazidine

Experimental group

Description:

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.

Treatment:

Drug: trimetazidine

placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo Oral Tablet