Prasugrel Or Ticagrelor De-escalation in NSTE-ACS (PROTEUS)

Collegium Medicum w Bydgoszczy

Status and phase: Not yet enrolling; Phase 3

Conditions: Unstable Angina; Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Non ST Segment Elevation Acute Coronary Syndrome

Treatments: Drug: Switch to ticagrelor 60 mg at day 45; Drug: De-escalation to ticagrelor 60 mg at day 30; Drug: Switch to prasugrel 5 mg at day 45; Drug: De-escalation to prasugrel 5 mg at day 30

Study type: Interventional

Funder types: Other

Identifiers

NCT05779059

2023/01

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Initial ticagrelor

Experimental group

Description:

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.

Treatment:

Drug: Switch to prasugrel 5 mg at day 45

Drug: De-escalation to ticagrelor 60 mg at day 30

Initial prasugrel

Experimental group

Description:

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.

Treatment:

Drug: Switch to ticagrelor 60 mg at day 45

Drug: De-escalation to prasugrel 5 mg at day 30