Non ST Segment Elevation Acute Coronary Syndrome, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Unstable Angina
Conditions
Keywords
acute coronary syndrome, de-escalation, prasugrel, ticagrelor
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).
Interventions
DRUGDe-escalation to ticagrelor 60 mg at day 30
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.
DRUGDe-escalation to prasugrel 5 mg at day 30
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.
DRUGSwitch to ticagrelor 60 mg at day 45
Switch to ticagrelor 60 mg bid at day 45.
DRUGSwitch to prasugrel 5 mg at day 45
Switch to prasugrel 5 mg qd at day 45.
Sponsors
Collegium Medicum w Bydgoszczy
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Reactivity Assessed with Multiple Electrode Aggregometry | day 15 of using reduced maintenance dose of prasugrel or ticagrelor | Platelet Reactivity Assessed with Multiple Electrode Aggregometry will be evaluated after 15 days of using reduced maintenance dose of prasugrel or ticagrelor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Reactivity Assessed with the VerifyNow assay | day 15 of using reduced maintenance dose of prasugrel or ticagrelor | Platelet Reactivity Assessed with the VerifyNow assay will be evaluated after 15 days of using reduced maintenance dose of prasugrel or ticagrelor. |
| High Platelet Reactivity according to Multiple Electrode Aggregometry | day 15 of using reduced maintenance dose of prasugrel or ticagrelor | Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry after 15 days of using reduced maintenance dose of prasugrel or ticagrelor. |
| High Platelet Reactivity according to the VerifyNow assay | day 15 of using reduced maintenance dose of prasugrel or ticagrelor | Percentage of Patients With High Platelet Reactivity according to the VerifyNow assay after 15 days of using reduced maintenance dose of prasugrel or ticagrelor. |
Countries
Poland
Contacts
Primary ContactPiotr Adamski, MD, PhD
Outcome results
None listed