Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04476173
Status:
RECRUITING
Last Update Posted:
2023-09-11
First Post:
2020-06-19
Brief Title:
ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction
Sponsor:
Collegium Medicum w Bydgoszczy
Organization:
Collegium Medicum w Bydgoszczy
Study Overview
Official Title:
ANalgesic Efficacy and Safety of MOrphiNe Versus Methoxyflurane in Patients With Acute Myocardial Infarction
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANEMON
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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None