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ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction (ANEMON)

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ClinicalTrials.gov Identifier: NCT04476173
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jacek Kubica, Collegium Medicum w Bydgoszczy

Brief Summary:
The purpose of this study is to evaluate analgesic efficacy of inhaled methoxyflurane vs intravenous morphine in patients presenting with acute ST-elevation (STEMI) / non ST-elevation acute coronary syndrome (NSTE-ACS)

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Non ST Segment Elevation Acute Coronary Syndrome Drug: Methoxyflurane - Penthrox Drug: Morphine Phase 3

Detailed Description:

Platelet activation plays a pivotal role in the pathophysiology of acute coronary syndromes (ACS). Pharmacological platelet inhibition with P2Y12 receptor antagonists and aspirin, together with percutaneous coronary intervention (PCI) are the cornerstone of treatment of ACS patients.

Chest pain and anxiety are both associated with sympathetic activation, which increases workload of the heart. Relieving of these symptoms in acute myocardial infarction (AMI) is expected to improve the balance between the demand for oxygen and its supply. Morphine, apart from its analgesic effects, also alleviates the work of breathing and reduces anxiety. However, despite its favourable analgesic and sedative actions, morphine also exerts adverse effects, which include vomiting and reduction of gastrointestinal motility. These side effects affect the intestinal absorption of oral drugs co-administered with morphine. Previously performed randomized studies revealed unfavourable influence of morphine on the pharmacokinetics of ticagrelor resulting in weaker and retarded antiplatelet effect.

Methoxyflurane was shown to be effective and well tolerated for the management of acute traumatic pain with a rapid onset of analgesia. As it does not affect the μ-opioid receptors, which inhibit propulsive motility and secretion of the gastro-intestinal tract, methoxyflurane is not expected to decrease or delay absorption or effects of orally administered drugs, including P2Y12 inhibitors, as well as to exert any other negative impact in patients with ACS.

Before PCI for the index ACS, after obtaining informed consent patients will be enrolled and randomly assigned with a secure on-line system in 1:1 ratio to one of two study arms. Patients in the intervention arm will receive methoxyphlurane administered by inhalation, whereas patients in the control arm will obtain morphine administered intravenously.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Methoxyflurane
Patients treated with inhaled methoxyflurane (3 mg)
Drug: Methoxyflurane - Penthrox
ACS patients who received inhaled methoxyflurane as analgesic treatment

Active Comparator: Morphine
Patients treated with intravenous morphine (5 mg)
Drug: Morphine
ACS patients who received intravenous morphine as analgesic treatment




Primary Outcome Measures :
  1. Measure of pain intensity according to the Numeric Pain Rating Scale (NPRS) 2-3 minutes after drug administration in relation to pain intensity assessed before drug administration [ Time Frame: 2-3 mins ]
    NPRS score before and 2-3 minutes after drug administration in each study arm

  2. Measure of pain intensity according to the Numeric Pain Rating Scale (NPRS) immediately after PCI in relation to pain intensity assessed before drug administration [ Time Frame: immediately after PCI ]
    NPRS score before drug administration and and immediately after PCI in each study arm


Secondary Outcome Measures :
  1. Adverse effects of evaluated therapies [ Time Frame: 24 hours ]
    nausea, vomiting, dry mouth, respiratory failure - need for intubation, headache, dizziness, drowsiness, loss of consciousness, death

  2. Need for GPIIb/IIIa (glycoprotein IIb/IIIa) inhibitor administration during PCI due to large intracoronary thrombus [ Time Frame: 24 hours ]
    The percentage of patients who required GP IIb/IIIa administration in each study arm

  3. Angiographic effect of PCI using Thrombolysis In Myocardial Infarction (TIMI) scale [ Time Frame: through study completion, an average of 1 year ]
    central analysis of coronary angiography after PCI according to Thrombolysis In Myocardial Infarction (TIMI) scale (TIMI 0 to TIMI 3; where TIMI 0 corresponds with no antegrade flow beyond the point of occlusion whereas TIMI 3 - normal flow with complete filling of the distal territory)

  4. Angiographic effect of PCI using TIMI Myocardial Perfusion Grade (TMPG) scale [ Time Frame: through study completion, an average of 1 year ]
    central analysis of coronary angiography after PCI according to TIMI Myocardial Perfusion Grade (TMPG) scale (TMPG 0 to TMPG 3, where TMPG 0 corresponds with failure of dye to enter the microvasculature, indicating a lack of tissue level perfusion whereas TMPG 3 - normal entry and exit of dye from the microvasculature)

  5. ST elevation resolution in STEMI patients after PCI [ Time Frame: 1 hour after PCI ]
    central analysis of ST elevation reduction in STEMI patients with a 70% resolution cut-off



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of ST-elevation myocardial infarction (STEMI) or non-ST-elevation acute coronary syndrome (NSTE-ACS)
  • patients aged from 18 to 80 years

Exclusion Criteria:

  • pregnancy
  • manifest infection or inflammatory state
  • cardiogenic shock during screening for eligibility
  • respiratory failure
  • heart failure (NYHA class III or IV during screening for eligibility)
  • uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg)

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): NCT04476173


Contacts
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Contact: Agata Kosobucka, PhD +48 525854023 akosobucka@wp.pl
Contact: Piotr Niezgoda, MD +48 525854023 piotr.niezgoda1986@gmail.com

Locations
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Poland
Department of Cardiology Recruiting
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-094
Contact: Agata Kosobucka, PhD    +48 525854023    akosobucka@wp.pl   
Principal Investigator: Jacek Kubica, Professor         
Sponsors and Collaborators
Collegium Medicum w Bydgoszczy
Investigators
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Principal Investigator: Jacek Kubica, Professor Collegium Medicum w Bydgoszczy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jacek Kubica, Professor, Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier: NCT04476173    
Other Study ID Numbers: ANEMON-SIRIO3
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Morphine
Methoxyflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General
Anesthetics