STEMI PCI P2Y12 receptor antagonists platelet inhibition Fantanyl Paracetamol Ambulance
Conditions
Interventions
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
Sponsors
Isala, Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: 1. age >17 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 0.1 mV in at least 2 contiguous leads 4. ongoing chest pain with a pain score (NRS) ¡Ý4 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
Exclusion criteria
Exclusion criteria: 1. presenting with cardiogenic shock; defined as: - systolic blood pressure 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. allergy to morphine or paracetamol 6. 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 7. received any organ transplant or is on a waiting list for any organ transplant 8. patients undergoing dialysis 9. pregnant or lactating female 10. patients currently participating in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to show that patients with STEMI who are pre-treated with crushed ticagrelor 180 mg and paracetamol 1000 mg have a higher level of platelet inhibition directly after primary PCI compared to patients pre-treated with crushed ticagrelor 180 mg and fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg. This is measured by the level of platelet reactivity units (PRU) at T2 (directly post-PCI or 1 hour post-angiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Pain reduction measured by the level of pain using numeric rating score. - The level of platelet inhibition (PRU) at T1, T3 and T4. - The percentage of High on treatment Platelet Reactivity (HPR) as defined as a PRU >208 (1) at T1, T2, T3 and T4. - The level of the active metabolite of a higher active metabolite of ticagrelor and AR-C124910XX measured in plasma, at T1, T2, T3 and T4. - Extent of ST-segment deviation (¡Ý70% ST- segment resolution) pre-PCI and 1 hour post-PCI. - TIMI flow grade 3 in the culprit vessel at initial angiography. - Requiring of fentanyl in patients randomized to paracetamol. - MACE and stent thrombosis at 30 days of follow-up. | — |
Contacts
Public ContactH. Wetering, van de
Outcome results
None listed