Clinical trial NCT03454841: Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
Official title: Comparison of Circadian Variability of Platelet Inhibition in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: prasugrel
ticagrelor
VASP
platelet reactivity
STEMI
NSTEMI
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute myocardial infarction treated invasively.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Circadian variability of platelet inhibition assessed with VASP
timeFrame: Day 4 after acute myocardial infarction
measure: Circadian variability of platelet inhibition assessed with Multiplate
timeFrame: Day 4 after acute myocardial infarction
Secondary outcomes:
measure: High platelet reactivity at 8:00 assessed with VASP
timeFrame: Day 4 after acute myocardial infarction
measure: High platelet reactivity at 12:00 assessed with VASP
timeFrame: Day 4 after acute myocardial infarction
measure: High platelet reactivity 16:00 assessed with VASP
timeFrame: Day 4 after acute myocardial infarction
measure: High platelet reactivity 20:00 assessed with VASP
timeFrame: Day 4 after acute myocardial infarction
measure: High platelet reactivity 08:00 assessed with Multiplate
timeFrame: Day 4 after acute myocardial infarction
measure: High platelet reactivity 12:00 assessed with Multiplate
timeFrame: Day 4 after acute myocardial infarction
measure: High platelet reactivity 16:00 assessed with Multiplate
timeFrame: Day 4 after acute myocardial infarction
measure: High platelet reactivity 20:00 assessed with Multiplate
timeFrame: Day 4 after acute myocardial infarction
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Cardiology, Wrocław Medical University
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
state: Kujawsko-pomorskie
Study officials:
affiliation: Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
name: Jacek Kubica, Prof.
role: PRINCIPAL_INVESTIGATOR
References: