NCT03715582

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	trimetazidine	Pills of masking drug - trimetazidine
DRUG	Placebo Oral Tablet	Pills of masking drug - placebo

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-10-01
• Completion: 2021-10-01
• First posted: 2018-10-23
• Last updated: 2018-10-24

Locations

1 site across 1 country: Brazil