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

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
De-escalation to ticagrelor 60 mg at day 30
De-escalation to prasugrel 5 mg at day 30
Switch to ticagrelor 60 mg at day 45
Switch to prasugrel 5 mg at day 45
Sponsored by
Collegium Medicum w Bydgoszczy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non ST Segment Elevation Acute Coronary Syndrome focused on measuring acute coronary syndrome, de-escalation, prasugrel, ticagrelor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Initial ticagrelor

Initial prasugrel

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Collegium Medicum w Bydgoszczy
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1. Study Identification

Unique Protocol Identification Number
NCT05779059
Brief Title
Prasugrel Or Ticagrelor De-escalation in NSTE-ACS
Acronym
PROTEUS
Official Title
Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collegium Medicum w Bydgoszczy

4. Oversight

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
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non ST Segment Elevation Acute Coronary Syndrome, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Unstable Angina
Keywords
acute coronary syndrome, de-escalation, prasugrel, ticagrelor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Initial ticagrelor
Arm Type
Experimental
Arm 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.
Arm Title
Initial prasugrel
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
De-escalation to ticagrelor 60 mg at day 30
Intervention Description
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.
Intervention Type
Drug
Intervention Name(s)
De-escalation to prasugrel 5 mg at day 30
Intervention Description
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.
Intervention Type
Drug
Intervention Name(s)
Switch to ticagrelor 60 mg at day 45
Intervention Description
Switch to ticagrelor 60 mg bid at day 45.
Intervention Type
Drug
Intervention Name(s)
Switch to prasugrel 5 mg at day 45
Intervention Description
Switch to prasugrel 5 mg qd at day 45.
Primary Outcome Measure Information:
Title
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
Description
Platelet Reactivity Assessed with Multiple Electrode Aggregometry will be evaluated after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.
Time Frame
day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Secondary Outcome Measure Information:
Title
Platelet Reactivity Assessed with the VerifyNow assay
Description
Platelet Reactivity Assessed with the VerifyNow assay will be evaluated after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.
Time Frame
day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Title
High Platelet Reactivity according to Multiple Electrode Aggregometry
Description
Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.
Time Frame
day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Title
High Platelet Reactivity according to the VerifyNow assay
Description
Percentage of Patients With High Platelet Reactivity according to the VerifyNow assay after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.
Time Frame
day 15 of using reduced maintenance dose of prasugrel or ticagrelor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Adamski, MD, PhD
Phone
+48 52 585 40 23
Email
piotr.adamski@cm.umk.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Adamski, MD, PhD
Organizational Affiliation
CM UMK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Adamski, MD, PhD
Phone
+48525854023
Email
piotr.adamski@cm.umk.pl

12. IPD Sharing Statement

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Prasugrel Or Ticagrelor De-escalation in NSTE-ACS

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