Influence of METHoxyflurane on ANtiplatelet Effect of Ticagrelor in Patients With Unstable Angina Pectoris

NCT04442919 | Completed Phase 4

• 1 other identifier: METHANE
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite in patients who received ticagrelor followed with methoxyflurane versus ticagrelor followed with morphine or ticagrelor alone due to unstable angina pectoris

Conditions

Unstable Angina

Outcome Measures

Primary Outcomes (1)

• Mean platelet reactivity between the study arms

  Mean platelet reactivity between the study arms, assessed using the Multiplate Analyzer

  6 hours

Secondary Outcomes (3)

• The percentage of high platelet reactivity patients (HPR) throughout the study period

  6 hours

• Mean time to achieve platelet reactivity below the threshold for HPR

  6 hours

• area under the plasma concentration-time curve for ticagrelor and its active metabolite between the study arms

  6 hours

Study Arms (3)

Ticagrelor followed with methoxyflurane

EXPERIMENTAL

patients who received ticagrelor followed with inhaled methoxyflurane due to unstable angina

Drug: Ticagrelor followed with Methoxyflurane

Ticagrelor followed with morphine

ACTIVE COMPARATOR

patients who received ticagrelor followed with intravenous morphine due to unstable angina

Drug: Ticagrelor followed with Morphine

Ticagrelor

ACTIVE COMPARATOR

patients who received ticagrelor without any analgesia due to unstable angina

Drug: Ticagrelor alone

Interventions

Ticagrelor followed with Methoxyflurane DRUG

patients who received ticagrelor followed with inhaled methoxyflurane due to unstable angina

Also known as: Brilique + Penthrox

Ticagrelor followed with methoxyflurane

Ticagrelor followed with Morphine DRUG

patients who received ticagrelor followed with intravenous morphine due to unstable angina

Also known as: Brilique + Morphine

Ticagrelor followed with morphine

Ticagrelor alone DRUG

patients who received ticagrelor without any analgesia due to unstable angina

Also known as: Brilique

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Diagnosis of unstable angina
• Male or non-pregnant female, aged 18-80 years
• Provision of informed consent for angiography and PCI
• GRACE score \<140 pts

You may not qualify if:

• Treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
• Current treatment with morphine or any opioid "mi" receptor agonist
• Hypersensitivity to ticagrelor
• Current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
• Active bleeding
• History of intracranial hemorrhage
• Recent gastrointestinal bleeding (within 30 days)
• History of coagulation disorders
• Platelet count less than \<100 x10\^3/mcl
• Hemoglobin concentration less than 10.0 g/dl
• History of moderate or severe hepatic impairment
• History of major surgery or severe trauma (within 3 months)
• Risk of bradycardic events as judged by the investigator
• Second- or third-degree atrioventricular block during screening for eligibility
• History of asthma or severe chronic obstructive pulmonary disease

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

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

Location

MeSH Terms

Conditions

Angina, Unstable

Interventions

Methoxyflurane; Ticagrelor; Morphine

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jacek Kubica, Professor

  Collegium Medicum w Bydgoszczy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: June 23, 2020
• Study Start: June 1, 2020
• Primary Completion: January 31, 2024
• Study Completion: February 29, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)