Non ST Segment Elevation Acute Coronary SyndromePhase 3PROTEUSNCT05779059
Prasugrel Or Ticagrelor De-escalation in NSTE-ACS
A Phase 3 study testing De-escalation to ticagrelor 60 mg at day 30, De-escalation to prasugrel 5 mg at day 30 and Switch to ticagrelor 60 mg at day 45 in people with Non ST Segment Elevation Acute Coronary Syndrome and Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Unstable Angina
- What is being tested?
- De-escalation to ticagrelor 60 mg at day 30, De-escalation to prasugrel 5 mg at day 30 and Switch to ticagrelor 60 mg at day 45
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
Piotr Adamski, MD, PhD, +48525854023, piotr.adamski@cm.umk.pl
About this study
Official title: Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome
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
- Being tested
- 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
- Keywords
- acute coronary syndrome, de-escalation, prasugrel, ticagrelor
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Angina, Unstable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-escalation to ticagrelor 60 mg at day 30Drug
Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30.
De-escalation to prasugrel 5 mg at day 30Drug
Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30.
Switch to ticagrelor 60 mg at day 45Drug
Switch to ticagrelor 60 mg bid at day 45.
Switch to prasugrel 5 mg at day 45Drug
Switch to prasugrel 5 mg qd at day 45.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: De-escalation to prasugrel 5 mg at day 30; Drug: Switch to ticagrelor 60 mg at day 45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Secondary outcomes (3)
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.
Measured: day 15 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.
Measured: day 15 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.
Measured: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Adamski, Collegium Medicum w Bydgoszczy
- Investigators
- Piotr Adamski, MD, PhD, Principal investigator, CM UMK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779059
- Sponsor's protocol ID
- 2023/01
- Acronym
- PROTEUS
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05779059
- Acronym / sponsor ID
- PROTEUS / 2023/01
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial ticagrelor | Experimental | Drug: De-escalation to ticagrelor 60 mg at day 30, Drug: Switch to prasugrel 5 mg at day 45All 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. |
| Initial prasugrel | Experimental | Drug: De-escalation to prasugrel 5 mg at day 30, Drug: Switch to ticagrelor 60 mg at day 45All 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De-escalation to ticagrelor 60 mg at day 30Change of P2Y12 receptor antagonist regimen to ticagrelor 60 mg bid at day 30. | Drug | Initial ticagrelor |
| De-escalation to prasugrel 5 mg at day 30Change of P2Y12 receptor antagonist regimen to prasugrel 5 mg qd at day 30. | Drug | Initial prasugrel |
| Switch to ticagrelor 60 mg at day 45Switch to ticagrelor 60 mg bid at day 45. | Drug | Initial prasugrel |
| Switch to prasugrel 5 mg at day 45Switch to prasugrel 5 mg qd at day 45. | Drug | Initial ticagrelor |
Primary outcome
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
Time frame: 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.
3 secondary outcomes
Platelet Reactivity Assessed with the VerifyNow assay
Time frame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
High Platelet Reactivity according to Multiple Electrode Aggregometry
Time frame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
High Platelet Reactivity according to the VerifyNow assay
Time frame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Adamski, MD, PhD principal investigator
CM UMK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing De-escalation to ticagrelor 60 mg at day 30, De-escalation to prasugrel 5 mg at day 30 and Switch to ticagrelor 60 mg at day 45 in people with Non ST Segment Elevation Acute Coronary Syndrome and Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Adamski, MD, PhD (+48 52 585 40 23, piotr.adamski@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Reactivity Assessed with Multiple Electrode Aggregometry (time frame: day 15 of using reduced maintenance dose of prasugrel or ticagrelor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.