Effect of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Myocardial Perfusion Score Index (MPSI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Ticagrelor
Patients will be randomized to have Ticagrelor 90mg BID
干预措施: Microbubble Contrasted Echocardiography (Diagnostic Test)
Ticagrelor
Patients will be randomized to have Ticagrelor 90mg BID
干预措施: Platelet Aggregability (Diagnostic Test)
Ticagrelor
Patients will be randomized to have Ticagrelor 90mg BID
干预措施: Laboratory (Diagnostic Test)
Clopidogrel
Patientes will be randomized to have Clopidogrel 75mg once a day
干预措施: Microbubble Contrasted Echocardiography (Diagnostic Test)
Clopidogrel
Patientes will be randomized to have Clopidogrel 75mg once a day
干预措施: Platelet Aggregability (Diagnostic Test)
Clopidogrel
Patientes will be randomized to have Clopidogrel 75mg once a day
干预措施: Laboratory (Diagnostic Test)
结局指标
主要结局
Myocardial Perfusion Score Index (MPSI)
时间窗: 4 (±3) days after Cardiac catheterization
Obtained using Microbubble Contrasted Echocardiography
次要结局
- MPSI in patients submitted to angioplasty(4 (±3) days after Cardiac catheterization)
- Platelet aggregability(4 (±3) days after Cardiac catheterization)
- 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)
- 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)
- Time Ticagrelor or Clopidogrel is administered(4 (±3) days after Cardiac catheterization)
- number of myocardial segments with perfusion deficit in coronary microcirculation(4 (±3) days after Cardiac catheterization)
研究者
Marco Antonio Scanavini Filho
Principal Investigator
University of Sao Paulo General Hospital