PROTEUS: Prasugrel Or Ticagrelor De-escalation in NSTE-ACS

Sponsor
Collegium Medicum w Bydgoszczy (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05779059
Collaborator
(none)
50
1
2
21
2.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: De-escalation to ticagrelor 60 mg at day 30
  • Drug: De-escalation to prasugrel 5 mg at day 30
  • Drug: Switch to ticagrelor 60 mg at day 45
  • Drug: Switch to prasugrel 5 mg at day 45
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: De-escalation to ticagrelor 60 mg at day 30
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.

Drug: Switch to prasugrel 5 mg at day 45
Switch to prasugrel 5 mg qd at day 45.

Experimental: 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.

Drug: De-escalation to prasugrel 5 mg at day 30
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.

Drug: Switch to ticagrelor 60 mg at day 45
Switch to ticagrelor 60 mg bid at day 45.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz Kujawsko-pomorskie Poland 85-094

Sponsors and Collaborators

  • Collegium Medicum w Bydgoszczy

Investigators

  • Principal Investigator: Piotr Adamski, MD, PhD, CM UMK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Piotr Adamski, MD, PhD, Associate Professor, Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier:
NCT05779059
Other Study ID Numbers:
  • 2023/01
First Posted:
Mar 22, 2023
Last Update Posted:
Mar 22, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Piotr Adamski, MD, PhD, Associate Professor, Collegium Medicum w Bydgoszczy
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2023