A randomised, investigator-initiated, clinical trial of the effects of fentanyl on P2Y12-receptor inhibition in patients with ST-elevation myocardial infarction who are pre-treated with crushed ticagrelor: rationale and design of the Opioids aNd crushed Ticagrelor In Myocardial infarction Evaluation (ON-TIME3) trial

A. H. Tavenier, R. S. Hermanides*, J. P. Ottervanger, S. Rasoul, R. J. Slingerland, R. Tolsma, S. van Workum, E. Kedhi, A. W. J. van 't Hof

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

BackgroundFast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by oral P2Y12-receptor antagonists are delayed in STEMI patients undergoing primary percutaneous coronary intervention (PCI) due to haemodynamic changes and delayed gastro-intestinal absorption. Concomitant use of opioids, although recommended in the American College of Cardiology/American Heart Association and European Society of Cardiology STEMI guidelines, further delays gastro-intestinal absorption. To date, trials investigating alternative analgesics in STEMI patients have been scarce. This trial aims to assess the feasibility of anovel drug strategy for treatment of STEMI patients with crushed ticagrelor in combination with paracetamol (acetaminophen) instead of opioids.HypothesisSTEMI patients who are pre-treated with crushed ticagrelor and paracetamol have ahigher level of platelet inhibition after primary PCI than patients pre-treated with crushed ticagrelor and fentanyl.Study designThe Opioids aNd crushed Ticagrelor In Myocardial infarction Evaluation (ON-TIME3) trial is arandomised controlled trial designed to examine whether administration of paracetamol instead of fentanyl can optimise platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance. One hundred and ninety patients with STEMI will be randomised (1:1fashion) to intravenous (IV) fentanyl or IV paracetamol. The primary endpoint is the level of platelet reactivity units measured immediately after primary PCI.SummaryThe ON-TIME3 trial (NCT03400267) aims to achieve optimal platelet inhibition and pain relief in STEMI patients receiving crushed ticagrelor in the ambulance by investigating IVfentanyl and IVparacetamol as analgesics.

Original languageEnglish
Pages (from-to)185-190
Number of pages6
JournalNetherlands Heart Journal
Volume27
Issue number4
DOIs
Publication statusPublished - Apr 2019

Keywords

  • ST-elevation myocardial infarction
  • Ticagrelor
  • Platelet inhibition
  • Primary percutaneous coronary intervention
  • Fentanyl
  • PERCUTANEOUS CORONARY INTERVENTION
  • TREATMENT PLATELET REACTIVITY
  • SEGMENT ELEVATION
  • MORPHINE USE
  • CARDIOVASCULAR EVENTS
  • INTRAVENOUS FENTANYL
  • TASK-FORCE
  • ACETAMINOPHEN
  • AGGREGATION
  • ASSOCIATION

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