Prasugrel Or Ticagrelor De-escalation in NSTE-ACS

Last updated: March 9, 2023
Sponsor: Collegium Medicum w Bydgoszczy
Overall Status: Active - Not Recruiting

Phase

3

Condition

Occlusions

Cardiac Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT05779059
2023/01
  • Ages 18-75
  • All Genders

Study Summary

The PROTEUS study is a randomized, cross-over, open-label, pharmacodynamic trial designed to compare the antiplatelet effect of reduced maintenance doses of prasugrel and ticagrelor in stable patients who recently had non-ST-elevation acute coronary syndrome (non-ST-elevation myocardial infarction or unstable angina).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • provision of informed consent prior to any study specific procedures
  • diagnosis of non-ST-segment elevation acute coronary syndrome (non-ST-segmentelevation myocardial treatment or unstable angina)
  • male or non-pregnant female, aged 18-75 years old

Exclusion

Exclusion Criteria:

  • known hypersensitivity to ticagrelor or prasugrel
  • presence of contraindications for ticagrelor or prasugrel
  • current treatment with oral anticoagulant or chronic therapy with low-molecular-weightheparin
  • 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
  • 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

Study Design

Total Participants: 50
Study Start date:
April 01, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

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

    Bydgoszcz, Kujawsko-pomorskie 85-094
    Poland

    Site Not Available

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