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Completed

NCT Number: NCT03104062

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

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.

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Key information

Conditions

Coronary Microvascular Disease Angina Pectoris Cardiovascular Diseases Heart Diseases Microbubble Contrasted Echocardiography Microvascular Angina Myocardial Ischemia Thrombolysis Ticagrelor Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Microbubble Contrasted Echocardiography

Diagnostic Test

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

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.

Primary outcomes

  1. Myocardial Perfusion Score Index (MPSI)

    Time frame: 4 (±3) days after Cardiac catheterization

    Obtained using Microbubble Contrasted Echocardiography

Secondary outcomes

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

    Time frame: after 90 days after discharge

    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

  2. number of myocardial segments with perfusion deficit in coronary microcirculation

    Time frame: 4 (±3) days after Cardiac catheterization

    To evaluate the number of myocardial segments with perfusion deficit in coronary microcirculation in the ticagrelor and clopidogrel groups

  3. MPSI in patients submitted to angioplasty

    Time frame: 4 (±3) days after Cardiac catheterization

    To evaluate MPSI in the subgroups of patients submitted to angioplasty and not submitted to angioplasty

  4. Patients who used clopidogrel prior to randomization and were randomized to ticagrelor

    Time frame: 4 (±3) days after Cardiac catheterization

    To evaluate MPSI in subgroups of patients who used clopidogrel prior to randomization and were randomized to ticagrelor

  5. Elective versus Urgent Percutaneous Coronary Intervention (PCI)

    Time frame: 4 (±3) days after Cardiac catheterization

    To compare the ticagrelor and clopidogrel groups in patients who had elective or urgent PCI

  6. Platelet aggregability

    Time frame: 4 (±3) days after Cardiac catheterization

    To evaluate the platelet aggregability in the ticagrelor and clopidogrel groups obtained immediately before Myocardial Contrasted Echocardiography (MCE) by Multiplate

  7. Time Ticagrelor or Clopidogrel is administered

    Time frame: 4 (±3) days after Cardiac catheterization

    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

Other outcomes

  1. Laboratory analysis

    Time frame: 4 (±3) days after Cardiac catheterization

    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);

  2. In hospital use of morphine (Yes or No)

    Time frame: 4 (±3) days after Cardiac catheterization

    Evaluate MPSI in patients who used Morphine or not.

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

    Time frame: 4 (±3) days after Cardiac catheterization

    Evaluate MPSI in patients who used PPI or not

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2017
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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