The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- platelet reactivity
研究概览
简要总结
Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-segment elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by normal oral P2Y12 receptor antagonists, for example ticagrelor, are delayed in STEMI patients undergoing primary percutaneous coronary intervention (primary PCI), which may be attributed to impaired absorption affecting drug pharmacokinetics (PK) and pharmacodynamics (PD). Another therapeutic goal in the acute treatment of STEMI is reduction of sympathetic stress and catecholamine release, thereby improving the balance between the demand for and supply of oxygen, by analgesia like fentanyl of morphine. To date, there are no studies that have specifically assessed the pharmacodynamics influences of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets. Therefore, In the ON-TIME-3 study, the investigators seek to show the influence of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. age ≥18 years
- •ii. referred by ambulance paramedics to Isala (Zwolle) or Zuyderland Hospital (Heerlen)
- •iii. diagnosed in the ambulance with STEMI defined as:
- •ongoing chest pain >30 minutes and <12 hours duration and
- •ST-segment elevation >0.1 milliVolt in at least 2 contiguous leads
- •iv. ongoing chest pain with a pain score (NRS) ≥4
- •v. 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
排除标准
- •i. presenting with cardiogenic shock; defined as:
- •systolic blood pressure <90 mmHg and
- •heart rate >100/min and
- •peripheral oxygen saturation <90% (without oxygen administration)
- •ii. patients with a nasogastric tube in situ or requiring a nasogastric tube
- •iii. patients who already received fentanyl or paracetamol <2 hours prior to randomization
- •iv. patients on current treatment with P2Y12 inhibitors (ticagrelor, clopidogrel or prasugrel)
- •v. allergy to morphine or paracetamol
- •vi. 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
- •active bleeding
- •refusal of blood transfusions
- •history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
- •known severe liver dysfunction
- •vii. received any organ transplant or is on a waiting list for any organ transplant
- •viii. patients undergoing dialysis
- •ix. pregnant or lactating female
- •x. patients currently participating in another investigational drug or device study
研究组 & 干预措施
paracetamol
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
干预措施: Paracetamol (Drug)
fentanyl
干预措施: Fentanyl (Drug)
结局指标
主要结局
platelet reactivity
时间窗: directly post-PCI or 1 hour post-angiography
Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography
次要结局
未报告次要终点
研究者
A.H. Tavenier
Master of Science
Isala