Clinical trial NCT05779059: Prasugrel Or Ticagrelor De-escalation in NSTE-ACS
Official title: Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non ST Segment Elevation Acute Coronary Syndrome
Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
Unstable Angina
Keywords: acute coronary syndrome
de-escalation
prasugrel
ticagrelor
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 Criteria:

* provision of informed consent prior to any study specific procedures
* 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:

* known hypersensitivity to ticagrelor or prasugrel
* 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

Primary outcomes:
measure: Platelet Reactivity Assessed with Multiple Electrode Aggregometry
timeFrame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Secondary outcomes:
measure: Platelet Reactivity Assessed with the VerifyNow assay
timeFrame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
measure: High Platelet Reactivity according to Multiple Electrode Aggregometry
timeFrame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
measure: High Platelet Reactivity according to the VerifyNow assay
timeFrame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
state: Kujawsko-pomorskie
Study officials:
affiliation: CM UMK
name: Piotr Adamski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: