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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Piotr Adamski, MD, PhD

Data sourced from clinicaltrials.gov

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