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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 PRU

High 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

Page last updated: August 23, 2015

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