Tavenier A H, Hermanides R S, Ottervanger J P, Rasoul S, Slingerland R J, Tolsma R, van Workum S, Kedhi E, van 't Hof A W J
Department of Cardiology, Isala, Zwolle, The Netherlands.
Department of Cardiology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Neth Heart J. 2019 Apr;27(4):185-190. doi: 10.1007/s12471-019-1241-6.
Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by oral P2Y12-receptor antagonists are delayed in STEMI patients undergoing primary percutaneous coronary intervention (PCI) due to haemodynamic changes and delayed gastro-intestinal absorption. Concomitant use of opioids, although recommended in the American College of Cardiology/American Heart Association and European Society of Cardiology STEMI guidelines, further delays gastro-intestinal absorption. To date, trials investigating alternative analgesics in STEMI patients have been scarce. This trial aims to assess the feasibility of a novel drug strategy for treatment of STEMI patients with crushed ticagrelor in combination with paracetamol (acetaminophen) instead of opioids.
STEMI patients who are pre-treated with crushed ticagrelor and paracetamol have a higher level of platelet inhibition after primary PCI than patients pre-treated with crushed ticagrelor and fentanyl.
The Opioids aNd crushed Ticagrelor In Myocardial infarction Evaluation (ON-TIME 3) trial is a randomised controlled trial designed to examine whether administration of paracetamol instead of fentanyl can optimise platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance. One hundred and ninety patients with STEMI will be randomised (1:1 fashion) to intravenous (IV) fentanyl or IV paracetamol. The primary endpoint is the level of platelet reactivity units measured immediately after primary PCI. The ON-TIME 3 trial (NCT03400267) aims to achieve optimal platelet inhibition and pain relief in STEMI patients receiving crushed ticagrelor in the ambulance by investigating IV fentanyl and IV paracetamol as analgesics.
快速且准确的血小板抑制是ST段抬高型心肌梗死（STEMI）患者急性治疗中的一个重要治疗目标。在接受直接经皮冠状动脉介入治疗（PCI）的STEMI患者中，口服P2Y12受体拮抗剂所诱导的血小板抑制作用会因血流动力学变化和胃肠道吸收延迟而延迟。尽管美国心脏病学会/美国心脏协会和欧洲心脏病学会的STEMI指南推荐使用阿片类药物，但同时使用会进一步延迟胃肠道吸收。迄今为止，针对STEMI患者使用替代镇痛药的试验很少。本试验旨在评估一种新型药物策略的可行性，即使用碾碎的替格瑞洛联合对乙酰氨基酚（扑热息痛）而非阿片类药物来治疗STEMI患者。
与预先接受碾碎的替格瑞洛和芬太尼治疗的患者相比，预先接受碾碎的替格瑞洛和对乙酰氨基酚治疗的STEMI患者在直接PCI后的血小板抑制水平更高。
心肌梗死中阿片类药物与碾碎的替格瑞洛评估（ON-TIME 3）试验是一项随机对照试验，旨在研究在救护车上预先接受碾碎的替格瑞洛治疗的STEMI患者中，使用对乙酰氨基酚而非芬太尼是否能优化血小板抑制。190例STEMI患者将被随机（1:1方式）分为静脉注射（IV）芬太尼组或IV对乙酰氨基酚组。主要终点是直接PCI后立即测量的血小板反应性单位水平。ON-TIME 3试验（NCT03400267）旨在通过研究将IV芬太尼和IV对乙酰氨基酚作为镇痛药，在救护车上接受碾碎的替格瑞洛治疗的STEMI患者中实现最佳的血小板抑制和疼痛缓解。
