Het effect van opiaten op de werking van bloedplaatjes (P2Y12 receptor remming) bij patiënten met een hartinfarct (ST-Elevation Myocardial Infarction) die vooraf worden behandeld met gemalenTicagrelor
- Conditions
- STEMIPCIP2Y12 receptor antagonistsplatelet inhibition FantanylParacetamolAmbulance
- Registration Number
- NL-OMON20881
- Lead Sponsor
- Isala, Zwolle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 190
Inclusion Criteria
1.age >17 years
2.referred by ambulance paramedics to Isala
(Zwolle) or Zuyderland Hospital (Heerlen)
Exclusion Criteria
1.presenting with cardiogenic shock; defined
as:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary endpoints: <br /><br>-Pain reduction measured by the level of <br> pain using numeric rating score. <br /><br>-The level of platelet inhibition (PRU) at T1, <br> T3 and T4. <br /><br>-The percentage of High on treatment <br> Platelet Reactivity (HPR) as defined as a <br> PRU >208 (1) at T1, T2, T3 and T4. <br /><br>-The level of the active metabolite of a <br> higher active metabolite of ticagrelor and <br> AR-C124910XX measured in plasma, at T1, <br> T2, T3 and T4. <br /><br>-Extent of ST-segment deviation (¡Ý70% ST-<br> segment resolution) pre-PCI and 1 hour <br> post-PCI. <br /><br>-TIMI flow grade 3 in the culprit vessel <br> at initial angiography. <br /><br>-Requiring of fentanyl in patients <br> randomized to paracetamol. <br /><br>-MACE and stent thrombosis at 30 days of <br> follow-up. <br>