Prasugrel Or Ticagrelor De-escalation in NSTE-ACS

NCT05779059 | Unknown Phase 3 DMC

• 1 other identifier: 2023/01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

acute coronary syndrome; de-escalation; prasugrel; ticagrelor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Platelet Reactivity Assessed with the VerifyNow assay

  day 15 of using reduced maintenance dose of prasugrel or ticagrelor

• High Platelet Reactivity according to Multiple Electrode Aggregometry

  day 15 of using reduced maintenance dose of prasugrel or ticagrelor

• High Platelet Reactivity according to the VerifyNow assay

  day 15 of using reduced maintenance dose of prasugrel or ticagrelor

Study Arms (2)

Initial ticagrelor

EXPERIMENTAL

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; Drug: Switch to prasugrel 5 mg at day 45

Initial prasugrel

EXPERIMENTAL

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; Drug: Switch to ticagrelor 60 mg at day 45

Interventions

De-escalation to ticagrelor 60 mg at day 30 DRUG

Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.

Initial ticagrelor

De-escalation to prasugrel 5 mg at day 30 DRUG

Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.

Initial prasugrel

Switch to ticagrelor 60 mg at day 45 DRUG

Switch to ticagrelor 60 mg bid at day 45.

Initial prasugrel

Switch to prasugrel 5 mg at day 45 DRUG

Switch to prasugrel 5 mg qd at day 45.

Initial ticagrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Angina, Unstable; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Piotr Adamski, MD, PhD

  CM UMK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Adamski, MD, PhD

CONTACT

+48 52 585 40 23; piotr.adamski@cm.umk.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

PL (1)