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

Diabetes Mellitus Clinical Trial

— Trimeta  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715582
• Other study ID #: PSInCor-Trimetazidine
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre Soeiro, MD
• Phone: +55112661-5299
• Email: alexandre.soeiro[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Diabetes Mellitus

Intervention

Drug:
• trimetazidine
Pills of masking drug - trimetazidine
• Placebo Oral Tablet
Pills of masking drug - placebo

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HMFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak values of troponin and CKMB after PCI	comparing groups for peak values of troponin and CKMB after PCI.	24 hours
Secondary	peak values of CRP	Comparison between groups for peak values of CRP after PCI.	24 hours
Secondary	peak values of creatinine	Comparison between groups for peak values of creatinine after PCI.	24 hours
Secondary	peak values of leukogram	Comparison between groups for peak values of leukogram after PCI.	24 hours
Secondary	occurrence of sustained ventricular arrhythmia	Combined comparison between the occurrence of sustained ventricular arrhythmia	24 hours
Secondary	occurrence of cardiogenic shock,	Combined comparison between the occurrence of cardiogenic shock,	24 hours
Secondary	occurrence of cardiorespiratory arrest,	Combined comparison between the occurrence of cardiorespiratory arrest	24 hours
Secondary	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
Secondary	occurrence of need for reintervention	Combined comparison between the occurrence of need for reintervention	24 hours
Secondary	occurrence of cerebrovascular accident	Combined comparison between the occurrence of cerebrovascular accident	24 hours
Secondary	occurrence of death	Combined comparison between the occurrence of death	24 hours