Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor (DRAGON)

Collegium Medicum w Bydgoszczy

Status

Completed

Conditions

Acute Myocardial Infarction

Treatments

Drug: Prasugrel

Drug: Ticagrelor

Study type

Observational

Funder types

Other

Identifiers

NCT03454841

CMUMK202I

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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