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Completed

NCT Number: NCT03454841

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prasugrel

Drug

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

Other names: Efient

Ticagrelor

Drug

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

Other names: Brilique

Primary outcomes

  1. Circadian variability of platelet inhibition assessed with VASP

    Time frame: Day 4 after acute myocardial infarction

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

  2. Circadian variability of platelet inhibition assessed with Multiplate

    Time frame: Day 4 after acute myocardial infarction

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

Secondary outcomes

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

    Time frame: Day 4 after acute myocardial infarction

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

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

    Time frame: Day 4 after acute myocardial infarction

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

  3. High platelet reactivity 16:00 assessed with VASP

    Time frame: Day 4 after acute myocardial infarction

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

  4. High platelet reactivity 20:00 assessed with VASP

    Time frame: Day 4 after acute myocardial infarction

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

  5. High platelet reactivity 08:00 assessed with Multiplate

    Time frame: Day 4 after acute myocardial infarction

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

  6. High platelet reactivity 12:00 assessed with Multiplate

    Time frame: Day 4 after acute myocardial infarction

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

  7. High platelet reactivity 16:00 assessed with Multiplate

    Time frame: Day 4 after acute myocardial infarction

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

  8. High platelet reactivity 20:00 assessed with Multiplate

    Time frame: Day 4 after acute myocardial infarction

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

Sponsors and collaborators

Lead sponsor

Collegium Medicum w Bydgoszczy

Other

Registry information

Official study title

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

Acronym: DRAGON

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2018
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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