Cangrelor vs. Ticagrelor for Early Platelet Inhibition in ST-elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Platelet reactivity 10 minutes PCI after is initiated
研究概览
简要总结
This randomized, controlled trial compares the anti-thrombotic effect of cangrelor and ticagrelor on platelet activity in patients with acute ST-elevation myocardial infarction.
Patients will receive either prehospital ticagrelor (180 mg - crushed) or in-hospital cangrelor (bolus 30 μg/kg within 1 minute followed by infusion (4 μg/kg/minute) for two hours) followed by 180 mg ticagrelor.
The primary study end-point is platelet reactivity at sheath insertion, at the end of the PCI procedure (before sheath removal) and two hours after PCI is initiated. The secondary end-point is the proportion of patients with inappropriate or harmful P2Y12 administration.
详细描述
In patients with ST-elevation myocardial infarction (STEMI) early restoration of blood flow in the culprit coronary artery is essential to reduce infarct size and thereby mortality and morbidity. The recommended method for achieving reperfusion is primary percutaneous coronary intervention (PPCI) (1,2). Early initiation of adjunctive antithrombotic therapy is important to prevent further thrombus formation and to facilitate PPCI.
International guidelines currently recommend immediate oral or intravenous administration of aspirin and intravenous administration of heparin in patients with suspected STEMI (1,2).
A second platelet inhibitor (of the P2Y12 family) is often added already in the ambulance. This enhances the antiplatelet effect, but also increases bleeding risk.
A recently introduced antithrombotic agent, that can be administered intravenously, can potentially achieve the same antithrombotic effect at the same time of the oral agent, with the added benefit, that administration can await coronary angiography. This would reduce the risk of administrating powerful antithrombotic medicine to patients with diagnosis other than STEMI.
In the ATLANTIC trial (3) prehospital administration was compared to in-hospital (catheterization laboratory) administration of ticagrelor. The trial indicated that ticagrelor could safely be administered in the ambulance, although there was no apparent effect on Thrombolysis in Myocardial Infarction (TIMI) flow in the culprit coronary artery and no effect on ST-segment resolution in the ECG. However, the median time difference between ticagrelor administration in the two groups was only 31 minutes. This might not leave enough time for adequate platelet inhibition in the prehospital group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients triaged for PPCI due to suspicion of STEMI.
- •Symptom duration < 12 hours
排除标准
- •Previous inclusion in the study
- •Already in treatment with ticagrelor, prasugrel or clopidogrel
- •Treatment with oral anticoagulants (warfarin, coumarins, rivaroxaban, apixaban, dabigatran)
- •Adjunctive use of glycoprotein IIb/IIIa inhibitor during PCI
- •Active bleeding
- •Known, severe kidney failure (GFR < 30 ml/min) and/or liver disease
- •Women of child bearing ability who are not using contraceptive medication
- •Severe mental or psychiatric disease, altered mental state (including unconsciousness) making it impossible to achieve informed consent
研究组 & 干预措施
Prehospital ticagrelor
Ticagrelor 180 mg orally administered in the ambulance as soon as possible after inclusion and before coronary angiography. The two pills are chewed and swallowed with a glass of water.
In both groups heparin and bivalirudin will be administered as part of routine therapy. In hemodynamically compromised patients with a high thrombus load a glycoprotein IIb/IIIa inhibitor may be used as bail-out therapy (these patients will be excluded). These drugs are not deemed to be study medication.
干预措施: Ticagrelor (Drug)
Inhospital cangrelor tetrasodium
Ticagrelor 180 mg orally in combination with cangrelor intravenously (bolus 30 μg/kg within 1 minute followed by infusion (4 μg/kg/minute) for two hours) both administered immediately after coronary angiography, when PPCI is indicated.
In both groups heparin and bivalirudin will be administered as part of routine therapy. In hemodynamically compromised patients with a high thrombus load a glycoprotein IIb/IIIa inhibitor may be used as bail-out therapy (these patients will be excluded). These drugs are not deemed to be study medication.
干预措施: Ticagrelor (Drug)
Inhospital cangrelor tetrasodium
Ticagrelor 180 mg orally in combination with cangrelor intravenously (bolus 30 μg/kg within 1 minute followed by infusion (4 μg/kg/minute) for two hours) both administered immediately after coronary angiography, when PPCI is indicated.
In both groups heparin and bivalirudin will be administered as part of routine therapy. In hemodynamically compromised patients with a high thrombus load a glycoprotein IIb/IIIa inhibitor may be used as bail-out therapy (these patients will be excluded). These drugs are not deemed to be study medication.
干预措施: Cangrelor Tetrasodium (Drug)
结局指标
主要结局
Platelet reactivity 10 minutes PCI after is initiated
时间窗: 10 minutes
Platelet reactivity measured in platelet reactivity units (PRU) by the VerifyNow® assay 10 minutes after PCI is initiated.
次要结局
- Platelet reactivity before and after PCI(2 hours)
- Proportion of patients with inappropriate or harmful P2Y12 administration(4 hours)
研究者
Jacob Sørensen
Md, PhD
University of Aarhus