NCT04476173

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

4.1 years

First QC Date

June 19, 2020

Last Update Submit

September 8, 2023

Conditions

ST Elevation Myocardial InfarctionNon ST Segment Elevation Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

    2-3 mins

  • 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

    immediately after PCI

Secondary Outcomes (5)

  • Adverse effects of evaluated therapies

    24 hours

  • Need for GPIIb/IIIa (glycoprotein IIb/IIIa) inhibitor administration during PCI due to large intracoronary thrombus

    24 hours

  • Angiographic effect of PCI using Thrombolysis In Myocardial Infarction (TIMI) scale

    through study completion, an average of 1 year

  • Angiographic effect of PCI using TIMI Myocardial Perfusion Grade (TMPG) scale

    through study completion, an average of 1 year

  • ST elevation resolution in STEMI patients after PCI

    1 hour after PCI

Study Arms (2)

Methoxyflurane

EXPERIMENTAL

Patients treated with inhaled methoxyflurane (3 mg)

Drug: Methoxyflurane - Penthrox

Morphine

ACTIVE COMPARATOR

Patients treated with intravenous morphine (5 mg)

Drug: Morphine

Interventions

Methoxyflurane - PenthroxDRUG

ACS patients who received inhaled methoxyflurane as analgesic treatment

Methoxyflurane
MorphineDRUG

ACS patients who received intravenous morphine as analgesic treatment

Morphine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33649058DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Morphine

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Jacek Kubica, Professor

    Collegium Medicum w Bydgoszczy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agata Kosobucka, PhD

CONTACT

+48 525854023akosobucka@wp.pl

Piotr Niezgoda, MD

CONTACT

+48 525854023piotr.niezgoda1986@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2020

First Posted

July 17, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)