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CompletedNCT03454841DRAGONUpdated Feb 26, 2020

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

An observational study in Acute Myocardial Infarction, sponsored by Collegium Medicum w Bydgoszczy. Completed at 2 sites in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Collegium Medicum w Bydgoszczy · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Myocardial Infarction

Keywords

  • prasugrel
  • ticagrelor
  • VASP
  • platelet reactivity
  • STEMI
  • NSTEMI
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute myocardial infarction treated invasively.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (actual)
Patient registry
No

Groups and cohorts

  • Prasugrel

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

    Drug: Prasugrel

  • Ticagrelor

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

    Drug: Ticagrelor

Interventions

  • DrugPrasugrel

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

    Also known as: Efient

  • DrugTicagrelor

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

    Also known as: Brilique

05

What researchers measure

Primary outcomes

  1. Circadian variability of platelet inhibition assessed with VASP

    Platelet inhibition evaluated with VASP assay at 8:00, 12:00, 16:00 and 20:00

    Time frame: Day 4 after acute myocardial infarction

  2. Circadian variability of platelet inhibition assessed with Multiplate

    Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00

    Time frame: Day 4 after acute myocardial infarction

Secondary outcomes

  1. High platelet reactivity at 8:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 8:00

    Time frame: Day 4 after acute myocardial infarction

  2. High platelet reactivity at 12:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 12:00

    Time frame: Day 4 after acute myocardial infarction

  3. High platelet reactivity 16:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 16:00

    Time frame: Day 4 after acute myocardial infarction

  4. High platelet reactivity 20:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 20:00

    Time frame: Day 4 after acute myocardial infarction

  5. High platelet reactivity 08:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 08:00

    Time frame: Day 4 after acute myocardial infarction

  6. High platelet reactivity 12:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 12:00

    Time frame: Day 4 after acute myocardial infarction

  7. High platelet reactivity 16:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 16:00

    Time frame: Day 4 after acute myocardial infarction

  8. High platelet reactivity 20:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 20:00

    Time frame: Day 4 after acute myocardial infarction

06

Study locations

2 sites
  • Department of Cardiology, Wrocław Medical University
    Wrocław, Dolnośląskie 50-556, Poland
  • Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
    Bydgoszcz, Kujawsko-pomorskie 85-094, Poland
07

Registry details

Key details

Study ID
NCT03454841
Lead sponsor
Collegium Medicum w Bydgoszczy
Responsible party
Jacek Kubica (Prof. dr hab., Collegium Medicum w Bydgoszczy) — Principal investigator
First posted
Mar 6, 2018
Start date
Feb 26, 2018
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
Feb 26, 2020

Study contacts

Jacek Kubica, Prof.
principal investigator · Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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