Prasugrel Or Ticagrelor De-escalation in NSTE-ACS

NCT05779059 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-22

No results posted yet for this study

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).

Conditions

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

Interventions

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

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.

DRUG

Switch to prasugrel 5 mg at day 45

Switch to prasugrel 5 mg qd at day 45.

Sponsors & Collaborators

  • Collegium Medicum w Bydgoszczy

    lead OTHER

Principal Investigators

  • Piotr Adamski, MD, PhD · CM UMK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779059 on ClinicalTrials.gov