Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Concentration of Platelet Extracellular Vesicles/ml
研究概览
简要总结
Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Informed consent to participate in the study
- •Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
- •Administration of a loading dose of clopidogrel
排除标准
- •Known coagulopathy
- •Known history of bleeding disorder
- •Suspicion of intracranial haemorrhage
- •Need for oral anticoagulation therapy
- •Administration of glycoprotein (GP) II b - III a antagonists
- •Cardiogenic shock
- •Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
- •Severe liver insufficiency
- •Chronic dyspnea
- •Increased risk of bradycardia
- •Autoimmune disease
- •Infectious disease
- •Neoplasms
- •Pregnancy
- •Study drug intolerance
- •Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
- •Participation in any previous study with ticagrelor or clopidogrel
研究组 & 干预措施
Ticagrelor
Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)
干预措施: Ticagrelor (Drug)
Clopidogrel
Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Concentration of Platelet Extracellular Vesicles/ml
时间窗: 6 months following the beginning of antiplatelet therapy
Concentration of platelet extracellular vesicles/ml measured with flow cytometry
次要结局
- Concentration of Extracellular Vesicles From Leukocytes(6 months)
- Concentration of Extracellular Vesicles Exposing Phosphatidylserine(6 months)
- Concentration of Extracellular Vesicles Exposing Fibrinogen(6 months)
- Concentration of Extracellular Vesicles From Endothelial Cells(6 months)
研究者
Aleksandra Gasecka
Medical Doctor
Medical University of Warsaw