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

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ClinicalTrials.gov Identifier: NCT03454841
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jacek Kubica, Collegium Medicum w Bydgoszczy

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Prasugrel Drug: Ticagrelor Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Circadian Variability of Platelet Inhibition in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Prasugrel
Patients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin.
Drug: Prasugrel
Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily
Other Name: Efient

Active Comparator: Ticagrelor
Patients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin.
Drug: Ticagrelor
Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily
Other Name: Brilique




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454841


Contacts
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Contact: Piotr Adamski, MD, PhD +48525854023 piotr.adamski@wp.eu

Locations
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Poland
Department of Cardiology, Wrocław Medical University Recruiting
Wrocław, Dolnośląskie, Poland, 50-556
Contact: Wiktor Kuliczkowski, MD, PhD    +48717842240    wkuliczkowski@wp.pl   
Principal Investigator: Wiktor Kuliczkowski, MD, PhD         
Sub-Investigator: Magdalena Cielecka-Prynda, MD         
Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-094
Contact: Piotr Adamski, MD, PhD    +48525854023    piotr.adamski@wp.eu   
Principal Investigator: Aldona Kubica, PhD         
Sub-Investigator: Piotr Adamski, MD, PhD         
Sub-Investigator: Małgorzata Ostrowska, MD, PhD         
Sponsors and Collaborators
Collegium Medicum w Bydgoszczy
Investigators
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Principal Investigator: Jacek Kubica, Prof. Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

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Responsible Party: Jacek Kubica, Prof. dr hab., Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier: NCT03454841     History of Changes
Other Study ID Numbers: CMUMK202I
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacek Kubica, Collegium Medicum w Bydgoszczy:
prasugrel
ticagrelor
VASP
platelet reactivity
STEMI
NSTEMI

Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs