Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2023-04-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Initial ticagrelor
All patients will receive standard 180 mg loading dose of ticagrelor, followed by a standard maintenance dose of 90 mg bid for 30 days, after which de-escalation to 60 mg bid will take place and this dosing will be maintained for 15 days. At day 45 all patients will be loaded with standard 60 mg dose of prasugrel followed by reduced maintenance dose of 5 mg qd for 15 days. At day 60 all patients will be switched back to guideline recommended antiplatelet therapy.
De-escalation to ticagrelor 60 mg at day 30
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.
Switch to prasugrel 5 mg at day 45
Switch to prasugrel 5 mg qd at day 45.
Initial prasugrel
All patients will receive standard 60 mg loading dose of prasugrel, followed by a standard maintenance dose 10 mg qd for 30 days, after which de-escalation to 5 mg qd will take place and this dosing will be maintained for 15 days. At day 45 patients will be loaded with standard 180 mg dose of ticagrelor followed by reduced maintenance dose of 60 mg bid for 15 days. At day 60 all patients will be switched back to guideline recommended antiplatelet therapy.
De-escalation to prasugrel 5 mg at day 30
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.
Switch to ticagrelor 60 mg at day 45
Switch to ticagrelor 60 mg bid at day 45.
Interventions
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De-escalation to ticagrelor 60 mg at day 30
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.
De-escalation to prasugrel 5 mg at day 30
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.
Switch to ticagrelor 60 mg at day 45
Switch to ticagrelor 60 mg bid at day 45.
Switch to prasugrel 5 mg at day 45
Switch to prasugrel 5 mg qd at day 45.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of non-ST-segment elevation acute coronary syndrome (non-ST-segment elevation myocardial treatment or unstable angina)
* male or non-pregnant female, aged 18-75 years old
Exclusion Criteria
* presence of contraindications for ticagrelor or prasugrel
* current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
* 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
18 Years
75 Years
ALL
No
Sponsors
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Collegium Medicum w Bydgoszczy
OTHER
Responsible Party
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Piotr Adamski
MD, PhD, Associate Professor
Principal Investigators
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Piotr Adamski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CM UMK
Locations
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Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023/01
Identifier Type: -
Identifier Source: org_study_id
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