Clinical trial NCT03715582: Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and Diabetes
Official title: PROSPECTIVE ANALYSIS BETWEEN TRIMETAZIDINE Versus PLACEBO IN MYOCARDIAL INJURY AFTER PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH INSTANT ANGINA AND DIABETES MELLITUS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus
Angina, Unstable
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: peak values of troponin and CKMB after PCI
timeFrame: 24 hours
Secondary outcomes:
measure: peak values of CRP
timeFrame: 24 hours
measure: peak values of creatinine
timeFrame: 24 hours
measure: peak values of leukogram
timeFrame: 24 hours
measure: occurrence of sustained ventricular arrhythmia
timeFrame: 24 hours
measure: occurrence of cardiogenic shock,
timeFrame: 24 hours
measure: occurrence of cardiorespiratory arrest,
timeFrame: 24 hours
measure: occurrence of worsening of renal function
timeFrame: 24 hours
measure: occurrence of need for reintervention
timeFrame: 24 hours
measure: occurrence of cerebrovascular accident
timeFrame: 24 hours
measure: occurrence of death
timeFrame: 24 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HMFMUSP
Study officials:
affiliation: Unidade Clínica de Emergência
name: Mucio Tavares, MD
role: PRINCIPAL_INVESTIGATOR
References: