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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 (PERSEUS)

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ClinicalTrials.gov Identifier: NCT02531165
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr Juan F. Iglesias, MD, Centre Hospitalier Universitaire Vaudois

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Fentanyl Drug: Morphine Drug: Ticagrelor Drug: Aspirin Drug: Unfractioned Heparin Procedure: Primary PCI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : February 6, 2018
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine


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 Name: 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: 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).

Drug: Ticagrelor
Pre-hospital Ticagrelor loading dose of 180 mg administered orally, followed by 90 mg bid
Other Name: 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.




Primary Outcome Measures :
  1. Residual platelet reactivity (PR) by Platelet Reactivity Units (PRU) [ Time Frame: 2 hours after loading dose of Ticagrelor ]

Secondary Outcome Measures :
  1. Residual PR by PRU [ Time Frame: 0, 1, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor ]
  2. High on Treatment Platelet Reactivity (HTPR) rates [ Time Frame: 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 [ Time Frame: at 1, 2, 4, 6 and 12 hours ]
  4. Time to peak plasma concentration (tmax) of Ticagrelor and AR-C124910XX [ Time Frame: at 1, 2, 4, 6 and 12 hours ]
  5. Area under the plasma concentration-time curve of Ticagrelor [ Time Frame: at 1, 2, 4, 6 and 12 hours ]
  6. Proportion of patients with 70% or greater resolution of the ST-segment elevation before PCI [ Time Frame: at 2 hours ]
  7. Proportion of patients without Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography [ Time Frame: at 2 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531165


Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
AstraZeneca
Investigators
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Principal Investigator: Juan F. Iglesias, MD Centre Hospitalier Universitaire Vaudois
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Juan F. Iglesias, MD, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02531165    
Other Study ID Numbers: ESR14-10591
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: February 2018
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Heparin
Fentanyl
Morphine
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics