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

NCT ID: NCT03454841

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2019-02-28

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.

Conditions

Acute Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prasugrel

Patients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin.

Prasugrel

Intervention Type: DRUG

Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily

Ticagrelor

Patients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin.

Ticagrelor

Intervention Type: DRUG

Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily

Interventions

Prasugrel

Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily

Intervention Type: DRUG

Ticagrelor

Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily

Intervention Type: DRUG

Other Intervention Names

Efient; Brilique

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Collegium Medicum w Bydgoszczy

OTHER

Sponsor Role: lead

Responsible Party

Jacek Kubica

Prof. dr hab.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacek Kubica, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

Locations

Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Department of Cardiology, Wrocław Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

CMUMK202I

Identifier Type: -

Identifier Source: org_study_id