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

Primary Purpose

ST Elevation Myocardial Infarction, Non ST Segment Elevation Acute Coronary Syndrome

Status
Recruiting
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Methoxyflurane - Penthrox
Morphine
Sponsored by
Collegium Medicum w Bydgoszczy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methoxyflurane

Morphine

Arm Description

Patients treated with inhaled methoxyflurane (3 mg)

Patients treated with intravenous morphine (5 mg)

Outcomes

Primary Outcome Measures

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
NPRS score before and 2-3 minutes after drug administration in each study arm
Measure of pain intensity according to the Numeric Pain Rating Scale (NPRS) immediately after PCI in relation to pain intensity assessed before drug administration
NPRS score before drug administration and and immediately after PCI in each study arm

Secondary Outcome Measures

Adverse effects of evaluated therapies
nausea, vomiting, dry mouth, respiratory failure - need for intubation, headache, dizziness, drowsiness, loss of consciousness, death
Need for GPIIb/IIIa (glycoprotein IIb/IIIa) inhibitor administration during PCI due to large intracoronary thrombus
The percentage of patients who required GP IIb/IIIa administration in each study arm
Angiographic effect of PCI using Thrombolysis In Myocardial Infarction (TIMI) scale
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)
Angiographic effect of PCI using TIMI Myocardial Perfusion Grade (TMPG) scale
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)
ST elevation resolution in STEMI patients after PCI
central analysis of ST elevation reduction in STEMI patients with a 70% resolution cut-off

Full Information

First Posted
June 19, 2020
Last Updated
September 8, 2023
Sponsor
Collegium Medicum w Bydgoszczy
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1. Study Identification

Unique Protocol Identification Number
NCT04476173
Brief Title
ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction
Acronym
ANEMON
Official Title
ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collegium Medicum w Bydgoszczy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, Non ST Segment Elevation Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methoxyflurane
Arm Type
Experimental
Arm Description
Patients treated with inhaled methoxyflurane (3 mg)
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Patients treated with intravenous morphine (5 mg)
Intervention Type
Drug
Intervention Name(s)
Methoxyflurane - Penthrox
Intervention Description
ACS patients who received inhaled methoxyflurane as analgesic treatment
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
ACS patients who received intravenous morphine as analgesic treatment
Primary Outcome Measure Information:
Title
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
Description
NPRS score before and 2-3 minutes after drug administration in each study arm
Time Frame
2-3 mins
Title
Measure of pain intensity according to the Numeric Pain Rating Scale (NPRS) immediately after PCI in relation to pain intensity assessed before drug administration
Description
NPRS score before drug administration and and immediately after PCI in each study arm
Time Frame
immediately after PCI
Secondary Outcome Measure Information:
Title
Adverse effects of evaluated therapies
Description
nausea, vomiting, dry mouth, respiratory failure - need for intubation, headache, dizziness, drowsiness, loss of consciousness, death
Time Frame
24 hours
Title
Need for GPIIb/IIIa (glycoprotein IIb/IIIa) inhibitor administration during PCI due to large intracoronary thrombus
Description
The percentage of patients who required GP IIb/IIIa administration in each study arm
Time Frame
24 hours
Title
Angiographic effect of PCI using Thrombolysis In Myocardial Infarction (TIMI) scale
Description
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)
Time Frame
through study completion, an average of 1 year
Title
Angiographic effect of PCI using TIMI Myocardial Perfusion Grade (TMPG) scale
Description
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)
Time Frame
through study completion, an average of 1 year
Title
ST elevation resolution in STEMI patients after PCI
Description
central analysis of ST elevation reduction in STEMI patients with a 70% resolution cut-off
Time Frame
1 hour after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agata Kosobucka, PhD
Phone
+48 525854023
Email
akosobucka@wp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Niezgoda, MD
Phone
+48 525854023
Email
piotr.niezgoda1986@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Kubica, Professor
Organizational Affiliation
Collegium Medicum w Bydgoszczy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology
City
Bydgoszcz
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
85-094
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agata Kosobucka, PhD
Phone
+48 525854023
Email
akosobucka@wp.pl
First Name & Middle Initial & Last Name & Degree
Jacek Kubica, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33649058
Citation
Kubica A, Kosobucka A, Niezgoda P, Adamski P, Buszko K, Lesiak M, Wojakowski W, Gasior M, Goracy J, Kleinrok A, Nadolny K, Navarese E, Kubica J. ANalgesic Efficacy and safety of MOrphiNe versus methoxyflurane in patients with acute myocardial infarction: the rationale and design of the ANEMON-SIRIO 3 study: a multicentre, open-label, phase II, randomised clinical trial. BMJ Open. 2021 Mar 1;11(3):e043330. doi: 10.1136/bmjopen-2020-043330.
Results Reference
derived

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

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