The effect of Opioids on P2Y12 Receptor Inhibition in patients with ST-Elevation Myocardial Infarction who are pre-treated with crushed Ticagrelor - ON-TIME-3

Isala0 个研究点目标入组 190 人开始时间: 2017年7月17日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•1.age =18 years
•2.referred by ambulance paramedics to Isala (Zwolle) or Zuyderland
•Hospital (Heerlen)
•3.diagnosed in the ambulance with STEMI defined as:
•- ongoing chest pain >30 minutes and <12 hours duration and
•- ST-segment elevation >0.1 mV in at least 2 contiguous leads
•4.ongoing chest pain with a pain score (NRS) =4
•5.the patient has been informed of the nature of the study, agrees
•to its provisions and has provided verbal informed consent in the
•pre-hospital phase followed by written informed consent in hospital
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 95
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 95

•A potential subject will be excluded from participation in this study when any of the following criteria is met:
•1.presenting with cardiogenic shock; defined as:
•-systolic blood pressure <90 mmHg and
•-heart rate >100/min and
•-peripheral oxygen saturation <90% (without oxygen
•administration)
•2.patients with a nasogastric tube in situ or requiring a nasogastric
•3.patients who already received fentanyl or paracetamol <2 hours
•prior to randomization
•4.patients on current treatment with P2Y12 inhibitors
•(ticagrelor, clopidogrel or prasugrel)
•5.patients with recent major bleeding complications or
•contraindication to dual antiplatelet therapy:
•-hypersensitivity to aspirin or ticagrelor
•-current use of (new) oral anticoagulation
•-history of bleeding diathesis or known coagulopathy
•-refusal of blood transfusions
•-history of intracerebral mass, aneurysm, arteriovenous
•malformation, or hemorrhagic stroke
•-known severe liver dysfunction
•6.received any organ transplant or is on a waiting list for any organ
•7.patients undergoing dialysis
•8.pregnant or lactating female
•9.patients currently participating in another investigational drug or
•device study

发起方