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

Isala Klinieken0 个研究点目标入组 190 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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

•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 tube
•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 herapy:
•- 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 transplant
•7. patients undergoing dialysis
•8. pregnant or lactating female
•9. patients currently participating in another investigational drug or device study

发起方

Isala Klinieken