The effect of Opioids on P2Y12 Receptor Inhibition in patients with ST-Elevation Myocardial Infarction who are pre-treated with crushed Ticagrelor.
- Conditions
- heart attackMyocardial infarction10011082
- Registration Number
- NL-OMON44492
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 190
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is:<br /><br>to show that patients with STEMI who are pre-treated with crushed ticagrelor<br /><br>180 mg and paracetamol 1000 mg have a higher level of platelet inhibition<br /><br>directly after primary PCI compared to patients pre-treated with crushed<br /><br>ticagrelor 180 mg and fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg.<br /><br>This is measured by the level of platelet reactivity units (PRU) at T2<br /><br>(directly post-PCI or 1 hour post-angiography) and by the percentage of High on<br /><br>Platelet Reactivity (HPR) as defined as a PRU >208 (1) at T2. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To demonstrate that paracetamol is non-inferior to fentanyl in pain reduction<br /><br>in STEMI patients, measured by the level of pain using NRS<br /><br>- The level of platelet inhibition (PRU) at T1, T3 and T4.<br /><br>- The percentage of High on treatment Platelet Reactivity (HPR) as defined as a<br /><br>PRU >208 at T1, T3 and T4.<br /><br>- The level of the active metabolite of a higher active metabolite of<br /><br>ticagrelor and AR-C124910XX measured in plasma, at T1, T2, T3 and T4.<br /><br>- Extent of ST-segment deviation (*70% ST-segment resolution) pre-PCI and 1<br /><br>hour post-PCI.<br /><br>- TIMI flow grade 3 in the culprit vessel at initial angiography.<br /><br>- Requiring of fentanyl in patients randomized to paracetamol.<br /><br>- MACE and stent thrombosis at 30 days of follow-up. </p><br>