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Unstable AnginaPhase 4METHANENCT04442919

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

A Phase 4 study testing Ticagrelor followed with Methoxyflurane, Ticagrelor followed with Morphine and Ticagrelor alone in people with Unstable Angina, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Unstable Angina
What is being tested?
Ticagrelor followed with Methoxyflurane, Ticagrelor followed with Morphine and Ticagrelor alone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 sitePoland
Study dates
1 Jun 2020to 29 Feb 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Kidney disease requiring dialysis
  • Manifest infection or inflammatory state
  • Killip class III or IV during screening for eligibility
  • Respiratory failure
  • History of severe chronic heart failure (NYHA class III or IV)
  • Concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
  • Body weight below 50 kg

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Cardiology Department, Dr. A. Jurasz University Hospital

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094

Other trials in Poland

About this study

Official title: Influence of METHoxyflurane on ANtiplatelet Effect of Ticagrelor in Patients With Unstable Angina Pectoris - METHANE Study

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

Read the detailed description

Results of the IMPRESSION trial published in 2015 proved that morphine use in patients with acute coronary syndromes (ACS) is associated with undesirable impact on pharmacokinetics (PK) and pharmacodynamics (PD) of ticagrelor. Despite that, morphine is still a standard analgesic treatment in ACS patients and it should not be routinely withdrawn. Based on contemporary knowledge, morphine, acting via mi-opioid receptors, was found to inhibit gastrointestinal motility or induce adverse effects such as nausea or vomiting.

We decided to design a clinical study aiming to evaluate the impact of methoxyflurane on PD of ticagrelor in patients diagnosed with unstable angina pectoris (UA). Methoxyflurane is an inhaled anesthetic, registered in Poland in emergency medicine for pain alleviation in trauma patients. The drug was widely used in 1960s to induce general anesthesia, however its clinical utility was reduced with the development of novel anesthetic agents. Taking into account its different mechanism of action, it can be presumed that, contrary to morphine, no respiratory depression should be observed as well as no attenuation or delay of antiaggregatory effect of ticagrelor should occur, as no interaction with mi-receptor in gastrointestinal tract is related to activity of methoxyflurane.

Patients will be randomized in a 1:1:1 ratio into the study arms as follows: 1) 180 mg ticagrelor (2 integral tablets of 90 mg ticagrelor) followed by 3 mg inhaled methoxyflurane, 2) 180 mg ticagrelor followed by 5 mg intravenous morphine, 3) 180 mg ticagrelor alone

Conditions
Unstable Angina
Being tested
Ticagrelor followed with Methoxyflurane, Ticagrelor followed with Morphine, Ticagrelor alone
Medical subject headings
Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ticagrelor followed with MethoxyfluraneDrug

    Also called Brilique + Penthrox

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

  • Ticagrelor followed with MorphineDrug

    Also called Brilique + Morphine

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

  • Ticagrelor aloneDrug

    Also called Brilique

    patients who received ticagrelor without any analgesia due to unstable angina

Study groups in NCT04442919
Study groupRoleWhat they receive
Ticagrelor followed with methoxyfluraneExperimentalpatients who received ticagrelor followed with inhaled methoxyflurane due to unstable angina
Receives: Drug: Ticagrelor followed with Methoxyflurane
Ticagrelor followed with morphineActive comparatorpatients who received ticagrelor followed with intravenous morphine due to unstable angina
Receives: Drug: Ticagrelor followed with Morphine
TicagrelorActive comparatorpatients who received ticagrelor without any analgesia due to unstable angina
Receives: Drug: Ticagrelor alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean platelet reactivity between the study arms

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

    Measured: 6 hours

Secondary outcomes (3)

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

    the percentage of patients with high platelet reactivity throughout the study period

    Measured: 6 hours

  2. Mean time to achieve platelet reactivity below the threshold for HPR

    Mean time required for patients to receive low platelet reactivity in each study arm

    Measured: 6 hours

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

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

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completion31 Jan 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04442919
Sponsor's protocol ID
METHANE
Acronym
METHANE
Status last verified
Mar 2024
First submitted
19 Jun 2020
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor followed with Methoxyflurane, Ticagrelor followed with Morphine and Ticagrelor alone in people with Unstable Angina, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean platelet reactivity between the study arms (time frame: 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04442919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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