Status:
COMPLETED
Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
Lead Sponsor:
Collegium Medicum w Bydgoszczy
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-75 years
Brief Summary
The aim of this study is to compare circadian variability of antiplatelet effect of prasugrel and ticagrelor maintenance doses during the initial days after acute myocardial infarction.
Detailed Description
Prasugrel and ticagrelor are two oral P2Y12 receptor antagonists recommended as a part of dual antiplatelet therapy with aspirin in patients with acute myocardial infarction. Both drugs exert comparab...
Eligibility Criteria
Inclusion
- provision of informed consent prior to any study specific procedures
- diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
- male or non-pregnant female, aged 18-75 years old
- provision of informed consent for angiography and percutaneous coronary intervention
Exclusion
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- hypersensitivity to ticagrelor or prasugrel
- contraindications for ticagrelor or prasugrel
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
- history of ischemic stroke or transient ischemic attack
- history of intracranial hemorrhage
- recent gastrointestinal bleeding (within 30 days)
- history of moderate or severe hepatic impairment
- history of major surgery or severe trauma (within 3 months)
- patient required dialysis
- manifest infection or inflammatory state
- 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 60 kg
Key Trial Info
Start Date :
February 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03454841
Start Date
February 26 2018
End Date
February 28 2019
Last Update
February 26 2020
Active Locations (2)
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1
Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-094
2
Department of Cardiology, Wrocław Medical University
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556