Status:
COMPLETED
Influence of METHoxyflurane on ANtiplatelet Effect of Ticagrelor in Patients With Unstable Angina Pectoris
Lead Sponsor:
Collegium Medicum w Bydgoszczy
Conditions:
Unstable Angina
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 methoxyflura...
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 pharmacody...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04442919
Start Date
June 1 2020
End Date
February 29 2024
Last Update
March 12 2024
Active Locations (1)
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1
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-094