Clinical Trials Directory

Trials / Completed

CompletedNCT03104062

Effect of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients With Acute Myocardial Infarction

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow, about 40% have flow alterations in the coronary microcirculation, which leads to worse remodeling of the left ventricle with a consequent increase in the mortality of this population. Clopidogrel is the only known antiplatelet medication that brings benefits to the coronary microcirculation. Ticagrelor is significantly superior to clopidogrel in terms of decreasing mortality. The main objective of this study is to compare the effect of ticagrelor versus clopidogrel on the coronary microcirculation by the Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography (MCE) in patients who have STEMI and treated with thrombolysis.

Detailed description

The present project should prospectively include patients participating in the TREAT study, who are including individuals with Acute Myocardial Infarction (AMI) treated with fibrinolytic and openly randomized to ticagrelor or clopidogrel within 24 hours of the onset of symptoms. Patients will be submitted to coronary angiography within 4 (± 2) days of the onset of symptoms, and those who, at the end of coronary angiography, present residual obstruction in the culprit vessel of less than 50% and have TIMI 3 flow, regardless of have undergone percutaneous coronary intervention will be included. Following, on day 2 (± 1) days after coronary angiography (therefore 6 ± 3 days from the onset of symptoms), they will be submitted to microcirculation perfusion evaluation by means of MPSI (myocardial perfusion score index) obtained by MCE (Microbubble contrasted echocardiography) - blood collection for evaluation of Platelet aggregability will be performed immediately prior to the start of MCE. Finally, in order to evaluate left ventricular remodeling, patients will undergo a new Echocardiography within 90 (± 10) days after discharge.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMicrobubble Contrasted EchocardiographyMyocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography
DIAGNOSTIC_TESTPlatelet AggregabilityObtained using Multiplate Analyzer
DIAGNOSTIC_TESTLaboratoryit will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine.

Timeline

Start date
2016-10-01
Primary completion
2018-02-01
Completion
2018-02-01
First posted
2017-04-07
Last updated
2018-05-18

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03104062. Inclusion in this directory is not an endorsement.