STEMI, STEMI - ST Elevation Myocardial Infarction
Conditions
Brief summary
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.
Interventions
DRUGParacetamol
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
DRUGFentanyl
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
Sponsors
Isala
A.H. Tavenier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled trial, with randomization to either paracetamol intravenously or fentanyl.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: 1. ongoing chest pain \>30 minutes and \<12 hours duration and 2. 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
Exclusion criteria
i. presenting with cardiogenic shock; defined as: 1. systolic blood pressure \<90 mmHg and 2. heart rate \>100/min and 3. 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: 1. hypersensitivity to aspirin or ticagrelor 2. current use of (new) oral anticoagulation 3. history of bleeding diathesis or known coagulopathy 4. active bleeding 5. refusal of blood transfusions 6. history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| platelet reactivity | directly post-PCI or 1 hour post-angiography | Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography |
Countries
Netherlands
Outcome results
None listed