NCT04442919CompletedPhase 4
Influence of METHoxyflurane on ANtiplatelet Effect of Ticagrelor in Patients With Unstable Angina Pectoris
Influence of METHoxyflurane on ANtiplatelet Effect of Ticagrelor in Patients With Unstable Angina Pectoris - METHANE Study
Source: ClinicalTrials.gov · Last updated 12 Mar 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 19 Jun 2020
- Start date
- 1 Jun 2020
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Diseases
- Coronary artery disease
- NCT number
- NCT04442919
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 72
- From 1 Jun 2020 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- Current treatment with morphine or any opioid "mi" receptor agonist
- Current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- 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
Other illness
- Hypersensitivity to ticagrelor
- Active bleeding
- History of intracranial hemorrhage
- Recent gastrointestinal bleeding (within 30 days)
- History of coagulation disorders
- History of moderate or severe hepatic impairment
- History of major surgery or severe trauma (within 3 months)
- History of asthma or severe chronic obstructive pulmonary disease
- Kidney disease requiring dialysis
- Manifest infection or inflammatory state
- Respiratory failure
- History of severe chronic heart failure (NYHA class III or IV)
Lab values
- Platelet count less than \<100 x10\^3/mcl
- Hemoglobin concentration less than 10.0 g/dl
Other
- Risk of bradycardic events as judged by the investigator
- Second- or third-degree atrioventricular block during screening for eligibility
- Killip class III or IV during screening for eligibility
- Body weight below 50 kg
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiology Department, Dr. A. Jurasz University Hospital Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.