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

Acute Myocardial Infarction Clinical Trial

— DRAGON  

Official title:

Comparison of Circadian Variability of Platelet Inhibition in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454841
• Other study ID #: CMUMK202I
• Status: Completed
• Start date: February 26, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2020
• Source: Collegium Medicum w Bydgoszczy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Prasugrel
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 a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily

Locations

Country	Name	City	State
Poland	Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University	Bydgoszcz	Kujawsko-pomorskie
Poland	Department of Cardiology, Wroclaw Medical University	Wroclaw	Dolnoslaskie

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian variability of platelet inhibition assessed with VASP	Platelet inhibition evaluated with VASP assay at 8:00, 12:00, 16:00 and 20:00	Day 4 after acute myocardial infarction
Primary	Circadian variability of platelet inhibition assessed with Multiplate	Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity at 8:00 assessed with VASP	Number of patients with high platelet reactivity evaluated with VASP assay at 8:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity at 12:00 assessed with VASP	Number of patients with high platelet reactivity evaluated with VASP assay at 12:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity 16:00 assessed with VASP	Number of patients with high platelet reactivity evaluated with VASP assay at 16:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity 20:00 assessed with VASP	Number of patients with high platelet reactivity evaluated with VASP assay at 20:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity 08:00 assessed with Multiplate	Number of patients with high platelet reactivity evaluated with Multiplate at 08:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity 12:00 assessed with Multiplate	Number of patients with high platelet reactivity evaluated with Multiplate at 12:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity 16:00 assessed with Multiplate	Number of patients with high platelet reactivity evaluated with Multiplate at 16:00	Day 4 after acute myocardial infarction
Secondary	High platelet reactivity 20:00 assessed with Multiplate	Number of patients with high platelet reactivity evaluated with Multiplate at 20:00	Day 4 after acute myocardial infarction