Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Information source: Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: Fentanyl (Drug); Morphine (Drug); Ticagrelor (Drug); Aspirin (Drug); Unfractioned Heparin (Drug); Primary PCI (Procedure)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Centre Hospitalier Universitaire Vaudois Official(s) and/or principal investigator(s): Juan F. Iglesias, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois
Overall contact: Juan F. Iglesias, MD, Phone: +41 79 556 30 84, Email: juan-fernando.iglesias@chuv.ch
Summary
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.
Clinical Details
Official title: Comparison of Analgesia With Fentanyl and Morphine on Platelet Inhibition After Pre-hospital Ticagrelor Administration in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Residual platelet reactivity (PR) by Platelet Reactivity Units (PRU)
Secondary outcome: Residual PR by PRUHigh on Treatment Platelet Reactivity (HTPR) rates Peak plasma concentration (Cmax) of Ticagrelor and AR-C124910XX Time to peak plasma concentration (tmax) of Ticagrelor and AR-C124910XX Area under the plasma concentration-time curve of Ticagrelor Proportion of patients with 70% or greater resolution of the ST-segment elevation before PCI Proportion of patients without Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age >18-year-old
- STEMI within 12 hours of symptoms' onset eligible for primary PCI with stent
implantation.
- Patient able to give written informed consent.
Exclusion Criteria:
- Contraindication, intolerance or hypersensitivity to Ticagrelor, or any excipients
- Contraindication, intolerance or hypersensitivity to Morphine, Fentanyl, or any
excipients
- Active bleeding or bleeding diathesis
- History of intracranial haemorrhage
- Chronic oral anticoagulation treatment
- Previous antiplatelet treatment
- Contraindications to antiplatelet therapy
- Severe renal insufficiency (creatinine clearance <30 mL/min)
- Severe hepatic dysfunction
- Severe chronic obstructive pulmonary disease
- Periprocedural glycoprotein IIb/IIIa inhibitors administration
- Relevant haematological disease
- Patient who is currently, plans, or has been enrolled in another clinical study
involving use of an investigational drug or device within the prior 30 days.
- If female, patient pregnant or breastfeeding.
Locations and Contacts
Juan F. Iglesias, MD, Phone: +41 79 556 30 84, Email: juan-fernando.iglesias@chuv.ch
Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud 1011, Switzerland; Not yet recruiting Juan F. Iglesias, MD, Phone: +41 79 556 30 84, Email: juan-fernando.iglesias@chuv.ch Olivier Muller, MD/PhD, Phone: +41 79 556 54 96, Email: olivier.muller@chuv.ch Juan F. Iglesias, MD, Principal Investigator Olivier Muller, MD/PhD, Sub-Investigator Fabrice Dami, MD, Sub-Investigator Eric Eeckhout, MD/PhD, Sub-Investigator Lorenzo Alberio, MD/PhD, Sub-Investigator Pierre Vogt, MD, Sub-Investigator Andrea Zuffi, MD, Sub-Investigator Sophie Degrauwe, MD, Sub-Investigator Stéphane Fournier, MD, Sub-Investigator
Additional Information
Starting date: September 2015
Last updated: August 21, 2015
|