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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Other | Patients will be randomized to have Ticagrelor 90mg BID |
|
| Clopidogrel | Other | Patientes will be randomized to have Clopidogrel 75mg once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbubble Contrasted Echocardiography | Diagnostic Test | Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Perfusion Score Index (MPSI) | Obtained using Microbubble Contrasted Echocardiography | 4 (±3) days after Cardiac catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular remodeling 90 days after de AMI, using Echocargiography parameters (End diastolic volume, end systolic volume and ejection Fraction) | To compare the parameters of left ventricular remodeling (End diastolic volume, End Systolic Volume, Ejection Fraction) at after 90 days after discharge from the ticagrelor and clopidogrel groups | after 90 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory analysis | Number of Participants With Abnormal Laboratory Values in both groups, Ticagrelor and Clopidogrel. The laboratory analysis will be: Platelet count; Platelet mean volume; HbA1C; Creatinine clearance; Reactive c-protein; Interleucine-6; Brain natriuretic peptide (BNP); Troponin; Creatine Kinase-MB (CK-MB); | 4 (±3) days after Cardiac catheterization |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute (InCor) - University of Sao Paulo Medical School | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35218519 | Derived | Scanavini-Filho MA, Berwanger O, Matthias W, Aguiar MO, Chiang HP, Azevedo L, Baracioli LM, Lima FG, Furtado RHM, Dalcoquio TF, Menezes FR, Ferrari AG, de Luca F, Giugliano RP, Goodman S, Nicolau JC. Effects of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients with Acute Myocardial Infarction. Adv Ther. 2022 Apr;39(4):1832-1843. doi: 10.1007/s12325-022-02061-0. Epub 2022 Feb 26. |
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| Platelet Aggregability | Diagnostic Test | Obtained using Multiplate Analyzer |
|
| Laboratory | Diagnostic Test | it will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine. |
|
| number of myocardial segments with perfusion deficit in coronary microcirculation | To evaluate the number of myocardial segments with perfusion deficit in coronary microcirculation in the ticagrelor and clopidogrel groups | 4 (±3) days after Cardiac catheterization |
| MPSI in patients submitted to angioplasty | To evaluate MPSI in the subgroups of patients submitted to angioplasty and not submitted to angioplasty | 4 (±3) days after Cardiac catheterization |
| Patients who used clopidogrel prior to randomization and were randomized to ticagrelor | To evaluate MPSI in subgroups of patients who used clopidogrel prior to randomization and were randomized to ticagrelor | 4 (±3) days after Cardiac catheterization |
| Elective versus Urgent Percutaneous Coronary Intervention (PCI) | To compare the ticagrelor and clopidogrel groups in patients who had elective or urgent PCI | 4 (±3) days after Cardiac catheterization |
| Platelet aggregability | To evaluate the platelet aggregability in the ticagrelor and clopidogrel groups obtained immediately before Myocardial Contrasted Echocardiography (MCE) by Multiplate | 4 (±3) days after Cardiac catheterization |
| Time Ticagrelor or Clopidogrel is administered | Evaluate the main objective of the study in two subgroups: 1) Ticagrelor or Clopidogrel administered less than 12 hours from the symptoms onset. 2) greater than or equal to 12 hours from the symptoms onset | 4 (±3) days after Cardiac catheterization |
| In hospital use of morphine (Yes or No) | Evaluate MPSI in patients who used Morphine or not. | 4 (±3) days after Cardiac catheterization |
| In hospital Use of Proton Pump Inhibitor (PPI) (yes or no) | Evaluate MPSI in patients who used PPI or not | 4 (±3) days after Cardiac catheterization |
| ID | Term |
|---|---|
| D017566 | Microvascular Angina |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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