Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (PERSEUS)

July 13, 2020 updated by: Dr Juan F. Iglesias, MD, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morphine
  • 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
Analgesia protocol using Morphine (initial dose: 4-8 mg, additional doses of 2 mg every 5-15 minutes to achieve adequate sedation, if required).
Drug: Ticagrelor
Pre-hospital Ticagrelor loading dose of 180 mg administered orally, followed by 90 mg bid
Other Names:
  • Brilique
Drug: Aspirin
500 mg loading dose orally (or intravenously), followed by 100 mg od
Drug: Unfractioned Heparin
5'000 IU loading dose intravenously, additional doses to achieve an ACT >250 sec during PCI are allowed.
Procedure: Primary PCI
Primary PCI with stent implantation according to the guidelines of the European Society of Cardiology.
Experimental: Fentanyl
  • 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: Ticagrelor
Pre-hospital Ticagrelor loading dose of 180 mg administered orally, followed by 90 mg bid
Other Names:
  • Brilique
Drug: Aspirin
500 mg loading dose orally (or intravenously), followed by 100 mg od
Drug: Unfractioned Heparin
5'000 IU loading dose intravenously, additional doses to achieve an ACT >250 sec during PCI are allowed.
Procedure: Primary PCI
Primary PCI with stent implantation according to the guidelines of the European Society of Cardiology.
Drug: Fentanyl
Analgesia protocol using Fentanyl (initial dose: 50-100 mcg, additional doses of 25 mcg every 2-5 minutes to achieve adequate sedation, if required).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Residual platelet reactivity (PR) by Platelet Reactivity Units (PRU)
Time Frame: 2 hours after loading dose of Ticagrelor
2 hours after loading dose of Ticagrelor

Secondary Outcome Measures

Outcome Measure
Time Frame
Residual PR by PRU
Time Frame: 0, 1, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor
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
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
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
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
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
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
at 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Juan F. Iglesias, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 24, 2015

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR14-10591

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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