Acute Coronary syndrome MedDRA version: 20.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000011652
Conditions
Interventions
Trade Name: Fentanyl Bipharma
Product Name: Fentanyl
Pharmaceutical Form: Solution for injection/infusion
Trade Name: Paracetamol B. Braun 10mg/ml solution for infusion
Product Name: Paracetamol
Prod
Sponsors
Isala
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 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 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 transplant 7.patients undergoing dialysis 8.pregnant or lactating female 9.patients currently participating in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Blood sample measurements for platelet function testing and level of active metabolite of ticagrelor, using Verify Now P2Y12 assay (Accumetrics, San Diego, California), will be done at four time points: T1: when arriving at the cathlab T2: directly post-primary PCI or 1 hour after coronary angiography when no PCI was performed T3: one hour post-primary PCI including electrocardiogram (ECG) or 2 hours post-coronary angiography T4: six hours post-primary PCI of 7 hours post-coronary angiography ;Main Objective: The aim of the study is to show that STEMI patients who are pre-treated with crushed ticagrelor and paracetamol have a higher level of platelet inhibition after primary PCI than patients pre-treated with crushed ticagrelor who are treated with fentanyl;Secondary Objective: -To demonstrate that paracetamol is non-inferior to fentanyl in pain reduction in STEMI patients. - To show that patients with STEMI who are pre-treated in the ambulance with crushed ticagrelor 180 mg and paracetamol have a higher level of platelet inhibition than patients pre-treated with crushed ticagrelor 180 mg and fentanyl at other time points (T1, T3, T4). - To show that patients with STEMI who are pre-treated in the ambulance with crushed ticagrelor 180 mg and paracetamol have a higher active metabolite of ticagrelor and AR-C124910XX measured in plasma than patients pre-treated with crushed ticagrelor 180 mg and fentanyl at the four time points (T1, T2, T3, T4). ;Primary end point(s): The priamry endpoint to show that patients with STEMI who are pre-treated in the ambulance with crushed ticagrelor 180 mg and paracetamol have a higher level of platelet inhibition directly after primary PCI (T2) than patients pre-treated with crushed ticagrelor 180 mg and fentanyl. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: -To demonstrate that paracetamol is non-inferior to fentanyl in pain reduction in STEMI patients, 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 at T1, 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 (=70% 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. ;Timepoint(s) of evaluation of this end point: Blood sample measurements for platelet function testing and level of active metabolite of ticagrelor, using Verify Now P2Y12 assay (Accumetrics, San Diego, California), will be done at the following time points: 1: when arriving at the cathlab 2: directly post-primary PCI or 1 hour after coronary angiography when no PCI was performed 3: one hour post-primary PCI including electrocardiogram (ECG) or 2 hours post-coronary angiography 4: six hours post-primary PCI of 7 hours post-coronary angiography - Hospital Discgarge - 30 days after Hospital Discharge | — |
Countries
Netherlands
Contacts
Public ContactH. van de Wetering
Diagram BV
Outcome results
None listed