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Acute Myocardial InfarctionPERSEUSNCT02531165

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

A study testing Fentanyl, Morphine and Ticagrelor in people with Acute Myocardial Infarction, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Fentanyl, Morphine and Ticagrelor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSwitzerland
Study dates
Sep 2015to 6 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Fentanyl, Morphine, Ticagrelor, Aspirin, Unfractioned Heparin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FentanylDrug

    Analgesia protocol using Fentanyl (initial dose: 50-100 mcg, additional doses of 25 mcg every 2-5 minutes to achieve adequate sedation, if required).

  • MorphineDrug

    Analgesia protocol using Morphine (initial dose: 4-8 mg, additional doses of 2 mg every 5-15 minutes to achieve adequate sedation, if required).

  • TicagrelorDrug

    Also called Brilique

    Pre-hospital Ticagrelor loading dose of 180 mg administered orally, followed by 90 mg bid

  • AspirinDrug

    500 mg loading dose orally (or intravenously), followed by 100 mg od

  • Unfractioned HeparinDrug

    5'000 IU loading dose intravenously, additional doses to achieve an ACT >250 sec during PCI are allowed.

  • Primary PCIProcedure or surgery

    Primary PCI with stent implantation according to the guidelines of the European Society of Cardiology.

Study groups in NCT02531165
Study groupRoleWhat they receive
MorphineExperimental* 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.
Receives: Drug: Morphine; Drug: Ticagrelor; Drug: Aspirin; Drug: Unfractioned Heparin; Procedure: Primary PCI
FentanylExperimental* 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.
Receives: Drug: Fentanyl; Drug: Ticagrelor; Drug: Aspirin; Drug: Unfractioned Heparin; Procedure: Primary PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Residual platelet reactivity (PR) by Platelet Reactivity Units (PRU)

    Measured: 2 hours after loading dose of Ticagrelor

Secondary outcomes (7)

  1. Residual PR by PRU

    Measured: 0, 1, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor

  2. High on Treatment Platelet Reactivity (HTPR) rates

    Measured: 0, 1, 2, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor

  3. Peak plasma concentration (Cmax) of Ticagrelor and AR-C124910XX

    Measured: at 1, 2, 4, 6 and 12 hours

  4. Time to peak plasma concentration (tmax) of Ticagrelor and AR-C124910XX

    Measured: at 1, 2, 4, 6 and 12 hours

  5. Area under the plasma concentration-time curve of Ticagrelor

    Measured: at 1, 2, 4, 6 and 12 hours

  6. Proportion of patients with 70% or greater resolution of the ST-segment elevation before PCI

    Measured: at 2 hours

  7. Proportion of patients without Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography

    Measured: at 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion6 Feb 2018
  4. Study completion6 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531165
Sponsor's protocol ID
ESR14-10591
Acronym
PERSEUS
Status last verified
Feb 2018
First submitted
18 Aug 2015
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Iglesias JF, Valgimigli M, Carbone F, Lauriers N, Giorgio Masci P, Degrauwe S. Effects of Fentanyl Versus Morphine on Ticagrelor-Induced Platelet Inhibition in Patients With ST-Segment Elevation Myocardial Infarction: The PERSEUS Randomized Trial. Circulation. 2020 Dec 22;142(25):2479-2481. doi: 10.1161/CIRCULATIONAHA.120.049287. Epub 2020 Dec 21. No abstract available.

    PubMed 33347326

  • Degrauwe S, Roffi M, Lauriers N, Muller O, Masci PG, Valgimigli M, Iglesias JF. Influence of intravenous fentanyl compared with morphine on ticagrelor absorption and platelet inhibition in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: rationale and design of the PERSEUS randomized trial. Eur Heart J Cardiovasc Pharmacother. 2019 Jul 1;5(3):158-163. doi: 10.1093/ehjcvp/pvy031.

    PubMed 30101278

Questions about this trial

What is this clinical trial studying?

A study testing Fentanyl, Morphine and Ticagrelor in people with Acute Myocardial Infarction, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Residual platelet reactivity (PR) by Platelet Reactivity Units (PRU) (time frame: 2 hours after loading dose of Ticagrelor). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02531165, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

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