Prasugrel Or Ticagrelor De-escalation in NSTE-ACS

Unstable Angina Clinical Trial

— PROTEUS  

Official title:

Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05779059
• Other study ID #: 2023/01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Collegium Medicum w Bydgoszczy
• Contact: Piotr Adamski, MD, PhD
• Phone: +48 52 585 40 23
• Email: piotr.adamski[@]cm.umk.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Non ST Segment Elevation Acute Coronary Syndrome
• Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
• Syndrome
• Unstable Angina

Intervention

Drug:
• De-escalation to ticagrelor 60 mg at day 30
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.
• De-escalation to prasugrel 5 mg at day 30
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.
• Switch to ticagrelor 60 mg at day 45
Switch to ticagrelor 60 mg bid at day 45.
• Switch to prasugrel 5 mg at day 45
Switch to prasugrel 5 mg qd at day 45.

Locations

Country	Name	City	State
Poland	Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University	Bydgoszcz	Kujawsko-pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Reactivity Assessed with Multiple Electrode Aggregometry	Platelet Reactivity Assessed with Multiple Electrode Aggregometry will be evaluated after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.	day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Secondary	Platelet Reactivity Assessed with the VerifyNow assay	Platelet Reactivity Assessed with the VerifyNow assay will be evaluated after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.	day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Secondary	High Platelet Reactivity according to Multiple Electrode Aggregometry	Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.	day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Secondary	High Platelet Reactivity according to the VerifyNow assay	Percentage of Patients With High Platelet Reactivity according to the VerifyNow assay after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.	day 15 of using reduced maintenance dose of prasugrel or ticagrelor