Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Ticagrelor is associated with more prompt and potent antiplatelet effects compared with
clopidogrel, leading to better clinical outcomes, including reduced cardiovascular mortality,
across the spectrum of patients with acute coronary syndrome, including those with
ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary
intervention (PCI). However, in this latter setting a delay in the onset of its antiplatelet
effects has been shown. Morphine has been identified as a cause of delayed P2Y12 inhibition
in patients with STEMI. Methylnaltrexone is a parenteral peripheral opioid receptor
antagonist which has the potential to prevent or reverse opioid-induced peripherally mediated
side effects without affecting analgesia. However, whether the use of intravenous
methylnaltrexone may overcome the effects of morphine administration on the pharmacokinetic
(PK) and pharmacodynamics (PD) profiles of ticagrelor has not been investigated yet. The
proposed investigation will include patients with coronary artery disease and will have a
prospective, randomized, cross-over design.