An interventional study of Fentanyl and Morphine in Acute Myocardial Infarction, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment
Prospective, randomized, open-label, single-center, investigator-initiated trial, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) within 12 hours of the symptom's onset. The study aims to compare platelet inhibition (pharmacodynamics and pharmacokinetics) of pre-hospital Ticagrelor in patients with STEMI according to two different analgesia protocols using Fentanyl or Morphine.
Consecutive patients with acute STEMI within 12 hours of the symptoms' onset and candidates for PPCI will be screened for inclusion in the study. Eligible patients who require analgesia for the relief of acute chest pain, defined as Visual Analogue Scale ≥3, will be randomized in a 1:1 ratio into one of the two treatment arms to receive analgesia with either Morphine or Fentanyl following administration of a pre-hospital loading dose of Ticagrelor. Randomized patients will undergo primary PCI and managed according to the current guidelines of the European Society of Cardiology. Blood samples (10 ml) will be collected at 0, 1, 2, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor to assess platelet inhibition using the VerifyNow P2Y12 function and the Vasodilator-Stimulated-phosphoprotein Phosphorylation (VASP) assays, plasma concentration of Ticagrelor and its active metabolite (AR-C124910XX) using a validated liquid chromatography/mass spectrometry detection method and the procoagulant action of platelets.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 38 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Pre-hospital Ticagrelor 180 mg loading dose orally. * Morphine, initial dose: 4-8 mg, additional doses of 2 mg every 5-15 minutes to achieve adequate sedation, if required. * Aspirin 500 mg loading dose orally (or intravenously). * Unfractioned heparin 5'000 IU loading dose intravenously, additional doses to achieve an ACT \>250 sec during PCI are allowed. * Primary PCI.
Drug: Morphine · Drug: Ticagrelor · Drug: Aspirin · Drug: Unfractioned Heparin · Procedure: Primary PCI
* Pre-hospital Ticagrelor 180 mg loading dose orally. * Fentanyl, initial dose: 50-100 mcg, additional doses of 25 mcg every 2-5 minutes to achieve adequate sedation, if required. * Aspirin 500 mg loading dose orally (or intravenously). * Unfractioned heparin 5'000 IU loading dose intravenously, additional doses to achieve an ACT \>250 sec during PCI are allowed. * Primary PCI.
Drug: Fentanyl · Drug: Ticagrelor · Drug: Aspirin · Drug: Unfractioned Heparin · Procedure: Primary PCI
Analgesia protocol using Fentanyl (initial dose: 50-100 mcg, additional doses of 25 mcg every 2-5 minutes to achieve adequate sedation, if required).
Analgesia protocol using Morphine (initial dose: 4-8 mg, additional doses of 2 mg every 5-15 minutes to achieve adequate sedation, if required).
Pre-hospital Ticagrelor loading dose of 180 mg administered orally, followed by 90 mg bid
Also known as: Brilique
500 mg loading dose orally (or intravenously), followed by 100 mg od
5'000 IU loading dose intravenously, additional doses to achieve an ACT \>250 sec during PCI are allowed.
Primary PCI with stent implantation according to the guidelines of the European Society of Cardiology.
Residual platelet reactivity (PR) by Platelet Reactivity Units (PRU)
Time frame: 2 hours after loading dose of Ticagrelor
Residual PR by PRU
Time frame: 0, 1, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor
High on Treatment Platelet Reactivity (HTPR) rates
Time frame: 0, 1, 2, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor
Peak plasma concentration (Cmax) of Ticagrelor and AR-C124910XX
Time frame: at 1, 2, 4, 6 and 12 hours
Time to peak plasma concentration (tmax) of Ticagrelor and AR-C124910XX
Time frame: at 1, 2, 4, 6 and 12 hours
Area under the plasma concentration-time curve of Ticagrelor
Time frame: at 1, 2, 4, 6 and 12 hours
Proportion of patients with 70% or greater resolution of the ST-segment elevation before PCI
Time frame: at 2 hours
Proportion of patients without Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography
Time frame: at 2 hours
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois