Platelet Inhibition in the Acute Phase of ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
研究概览
简要总结
Background:
Dual antithrombotic treatment with aspirin and clopidogrel is recommended in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The European Society of Cardiology (ESC) Guidelines recommend a bolus dose of aspirin of 250-500 mg and a 600 mg bolus dose of clopidogrel as soon as STEMI is suspected. Studies have shown that more newly produced platelets are present in the acute phase of STEMI, and it is likely that these immature platelets are haemostatically more active and might be of importance in thrombus formation.
The enhanced platelet reactivity may reduce the effect of aspirin and clopidogrel in the acute phase of STEMI compared to measurements made in the same patients 3 months after primary PCI.
Aim:
This study aims to compare platelet response to aspirin and clopidogrel in the acute phase of STEMI with the platelet response in the same patients 3 months after STEMI .
Design:
This study is an observational follow-up study.
Materials and methods:
46 patients with STEMI referred to primary PCI at Aarhus University Hospital, Skejby will be included in the study. A total of 3 blood samples are obtained in the acute phase of STEMI: Prior to primary PCI (Blood sample 1), at 4 hours (Blood sample 2) and at 12 hours (Blood sample 3) after administration of loading dose aspirin and clopidogrel. When patients are in a stable phase 3 month later, a final blood sample is taken (Blood sample 4). The blood is analyzed 30 minutes after withdrawal of blood by the platelet aggregation test Multiplate® aggregometry (agonists: Collagen, arachidonic acid and adenosinediphosphate) and VerifyNow® arachidonic acid and P2Y12 aggregometry. Platelet count, volume and the immature platelet fraction (IPF) will be measured using Sysmex® flowcytometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years of age
- •Patients with ST-segment elevation myocardial infarction (STEMI) referred to primary PCI at University Hospital of Aarhus, Skejby.
排除标准
- •Treatment with NSAID, ticlopidine and dipyramidole.
- •Treatment with anticoagulants (Vitamin K antagonists)
- •Patients diagnosed with platelet disease or haemophilia.
- •Patients unable to give written, informed consent to participation in this project.
结局指标
主要结局
Difference between aggregation induced by agonist arachidonic acid (1,0 mM) measured by Multiplate® Aggregometry (Unit=AUC).
时间窗: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (6,4 µM) measured by Multiplate® Aggregometry (Unit=AUC).
时间窗: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist adenosine diphosphate (20 µM) measured by Multiplate® Aggregometry (Unit=AUC).
时间窗: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the P2Y12-kit (Unit = PRU).
时间窗: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation induced by agonist collagen (1 μg/ml) measured by Multiplate® Aggregometry (Unit=AUC).
时间窗: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
Difference between aggregation measured by VerifyNow® Aggregometry using the ASPI-kit (Unit = ARU).
时间窗: Approximately 2-3 months
Outcome is the difference between aggregation measurements. In this case between: Blood sample 3: 12 hours after administration of LD aspirin and clopidogrel. Blood sample 4: 2-3 months after primary PCI.
次要结局
- Difference in immature platelet fraction measured by Sysmex® flowcytometry.(Approximately 2-3 months)
- Difference in serum P-selectin(Approximately 2-3 months)
- Difference in serum trombopoietin(Approximately 2-3 months)
- Difference in serum thromboxane B2(Approximately 2-3 months)