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

NCT03104062 | Completed

• 1 other identifier: 4416
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Microvascular Disease; Ticagrelor; Thrombolysis; Microbubble Contrasted Echocardiography

Outcome Measures

Primary Outcomes (1)

• Myocardial Perfusion Score Index (MPSI)

  Obtained using Microbubble Contrasted Echocardiography

  4 (±3) days after Cardiac catheterization

Secondary Outcomes (7)

• Left ventricular remodeling 90 days after de AMI, using Echocargiography parameters (End diastolic volume, end systolic volume and ejection Fraction)

  after 90 days after discharge

• number of myocardial segments with perfusion deficit in coronary microcirculation

  4 (±3) days after Cardiac catheterization

• MPSI in patients submitted to angioplasty

  4 (±3) days after Cardiac catheterization

• 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)

  4 (±3) days after Cardiac catheterization

Other Outcomes (3)

• Laboratory analysis

  4 (±3) days after Cardiac catheterization

• In hospital use of morphine (Yes or No)

  4 (±3) days after Cardiac catheterization

• In hospital Use of Proton Pump Inhibitor (PPI) (yes or no)

  4 (±3) days after Cardiac catheterization

Study Arms (2)

Ticagrelor

OTHER

Patients will be randomized to have Ticagrelor 90mg BID

Diagnostic Test: Microbubble Contrasted Echocardiography; Diagnostic Test: Platelet Aggregability; Diagnostic Test: Laboratory

Clopidogrel

OTHER

Patientes will be randomized to have Clopidogrel 75mg once a day

Diagnostic Test: Microbubble Contrasted Echocardiography; Diagnostic Test: Platelet Aggregability; Diagnostic Test: Laboratory

Interventions

Microbubble Contrasted Echocardiography DIAGNOSTIC_TEST

Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography

Clopidogrel; Ticagrelor

Platelet Aggregability DIAGNOSTIC_TEST

Obtained using Multiplate Analyzer

Clopidogrel; Ticagrelor

Laboratory DIAGNOSTIC_TEST

it will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine.

Clopidogrel; Ticagrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age from 18 years old to 75 years old.
• Patients with a ST-segment elevation AMI with up to 24 hours duration, documented by ischemic symptoms due to atherosclerosis\> 10 minutes at rest, treated with pharmacological thrombolysis, acetylsalicylic acid (ASA) and Clopidogrel or Ticagrelor.
• Cardiac catheterization performed within 4 (± 2) days of the onset of symptoms, which at the end of coronary angiography showed residual obstruction in the "culprit" artery \<50% with TIMI 3 flow regardless of whether or not the percutaneous coronary intervention was performed.

You may not qualify if:

• Previous infarction known from the same wall as the current one
• Any contraindication to the use of Clopidogrel or Ticagrelor
• Need for oral anticoagulation therapy or aspirin doses greater than 100mg per day.
• Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
• High risk of bradyarrhythmias
• Dialysis therapy
• Clinically important thrombocytopenia known
• Clinically Significant Anemia
• Pregnancy or lactation
• Contraindications to fibrinolytic therapy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Heart Institute (InCor) - University of Sao Paulo Medical School

São Paulo, 05403000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 35218519 DERIVED

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 7, 2017
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)