Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
- Registration Number
- NCT03454841
- Lead Sponsor
- Collegium Medicum w Bydgoszczy
- 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 comparable antiplatelet effect following a loading dose. However, pharmacodynamic differences exist between these P2Y12 receptor inhibitors. Prasugrel is a prodrug that requires hepatic activation and permanently binds to platelet P2Y12 receptors, whereas ticagrelor is an active drug and blocks P2Y12 receptors reversibly. Another important difference is that prasugrel maintenance dose is administered once daily, while ticagrelor requires next dosage every 12 hours. These fundamental distinctions may affect the degree of platelet inhibition on maintenance doses during the first days after acute myocardial infarction.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prasugrel Prasugrel Patients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin. Ticagrelor Ticagrelor Patients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin.
- Primary Outcome Measures
Name Time Method Circadian variability of platelet inhibition assessed with VASP Day 4 after acute myocardial infarction Platelet inhibition evaluated with VASP assay at 8:00, 12:00, 16:00 and 20:00
Circadian variability of platelet inhibition assessed with Multiplate Day 4 after acute myocardial infarction Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00
- Secondary Outcome Measures
Name Time Method High platelet reactivity at 8:00 assessed with VASP Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with VASP assay at 8:00
High platelet reactivity at 12:00 assessed with VASP Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with VASP assay at 12:00
High platelet reactivity 16:00 assessed with VASP Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with VASP assay at 16:00
High platelet reactivity 20:00 assessed with VASP Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with VASP assay at 20:00
High platelet reactivity 08:00 assessed with Multiplate Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with Multiplate at 08:00
High platelet reactivity 12:00 assessed with Multiplate Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with Multiplate at 12:00
High platelet reactivity 16:00 assessed with Multiplate Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with Multiplate at 16:00
High platelet reactivity 20:00 assessed with Multiplate Day 4 after acute myocardial infarction Number of patients with high platelet reactivity evaluated with Multiplate at 20:00
Trial Locations
- Locations (2)
Department of Cardiology, Wrocław Medical University
🇵🇱Wrocław, Dolnośląskie, Poland
Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland