A Phase 3 interventional study of Methoxyflurane - Penthrox and Morphine in ST Elevation Myocardial Infarction and Non ST Segment Elevation Acute Coronary Syndrome, sponsored by Collegium Medicum w Bydgoszczy. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Collegium Medicum w Bydgoszczy · Phase 3, Interventional, and Treatment
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)
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.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 200 is close to the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Collegium Medicum w Bydgoszczy is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated with inhaled methoxyflurane (3 mg)
Drug: Methoxyflurane - Penthrox
Patients treated with intravenous morphine (5 mg)
Drug: Morphine
ACS patients who received inhaled methoxyflurane as analgesic treatment
ACS patients who received intravenous morphine as analgesic treatment
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
Time frame: 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
Time frame: immediately after PCI
Adverse effects of evaluated therapies
nausea, vomiting, dry mouth, respiratory failure - need for intubation, headache, dizziness, drowsiness, loss of consciousness, death
Time frame: 24 hours
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
Time frame: 24 hours
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)
Time frame: through study completion, an average of 1 year
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)
Time frame: through study completion, an average of 1 year
ST elevation resolution in STEMI patients after PCI
central analysis of ST elevation reduction in STEMI patients with a 70% resolution cut-off
Time frame: 1 hour after PCI
Plan to share: No
Started Jun 2020 (actual). Primary completion is estimated for Jun 2024, 48 months after the start.
Of 38 phase 3 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 48 months is above that.
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Studies of the drug tested here: Methoxyflurane
ST Elevation Myocardial Infarction →
Collegium Medicum w Bydgoszczy