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Coronary Artery DiseasePhase 4POEMNCT03112707

Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT

A Phase 4 study testing Aspirin and P2Y12 inhibitor in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Humanitas Hospital, Italy at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aspirin and P2Y12 inhibitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,023 participants
Where
1 siteItaly
Study dates
14 Apr 2017to 1 May 2020
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients will need to have symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, or acute coronary syndromes (including NSTE-ACS and STE-ACS) and presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft that treated with one or multiple Synergy® stents.
  • Moreover, in order to be included patients will need to meet at least 1 of the following HBR criteria:
  • Age ≥75 years
  • Oral anticoagulation planned to continue after PCI
  • Hemoglobin <11 g/l,
  • Transfusion within 4 week before inclusion
Show all 16Show fewer
  • Platelet count <100'000
  • Hospital admission for bleeding in previous 12 months
  • Stroke in previous 12 months
  • History of intracerebral hemorrhage
  • Severe chronic liver disease
  • Creatinine clearance <40 ml/min
  • Cancer in previous 3 years
  • Planned major surgery in next 12 months
  • Glucocorticoids or NSAID planned for >30 days after PCI
  • Expected non-adherence to >30 days of dual antiplatelet therapy

Who cannot join

  • Cardiogenic shock
  • Major active bleeding at the time of PCI
  • Expected non-adherence with 1 month DAPT
  • Known intolerance to aspirin, clopidogrel, or ticagrelor
  • Inability to provide informed consent
  • Currently participating in another trial before reaching first endpoint

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

  • Humanitas Research Hospital

    Rozzano, Milan, 20089

    Giulio Stefanini, MD, PhD, 0282247384, giulio.stefanini@hunimed.eu

    Giulio Stefanini, MD, PhD

    Recruiting

Other trials in Italy

About this study

Official title: Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy® Stent in Patients at High Bleeding Risk Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy

Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk.

Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions.

Read more

Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm, multicentre trial, powered for non-inferiority with respect to objective performance criteria (OPC).

Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.

Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 1-year follow-up.

Being tested
Aspirin, P2Y12 inhibitor
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.

  • P2Y12 inhibitorDrug

    After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.

Study groups in NCT03112707
Study groupRoleWhat they receive
Study armExperimental1023 real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions will be included in the study.
Receives: Drug: Aspirin; Drug: P2Y12 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Events (MACE)

    Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis

    Measured: 1 year

Secondary outcomes (10)

  1. All-cause death

    All-cause death

    Measured: 30 days and 1 year

  2. Cardiac death

    Cardiac death

    Measured: 30 days and 1 year

  3. Myocardial infarction

    Myocardial infarction (defined according to III universal definition)

    Measured: 30 days and 1 year

  4. Stent thrombosis

    Stent thrombosis (defined according to ARC criteria)

    Measured: 30 days and 1 year

  5. Target-vessel revascularization

    Target-vessel revascularization (any and clinically driven)

    Measured: 30 days and 1 year

  6. Target-lesion revascularization

    Target-lesion revascularization (any and clinically driven)

    Measured: 30 days and 1 year

  7. Major bleeding

    Major bleeding (BARC 3 to 5)

    Measured: 30 days and 1 year

  8. Cerebrovascular event

    Cerebrovascular event

    Measured: 30 days and 1 year

  9. Target-lesion failure

    composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization

    Measured: 30 days and 1 year

  10. Patient oriented composite endpoint

    Composite of any death, any MI, any revascularization

    Measured: 30 days and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start14 Apr 2017
  3. Primary completion1 May 2020 (estimated)
  4. Study completion1 May 2020 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,023 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112707
Sponsor's protocol ID
012017POEM
Acronym
POEM
Status last verified
Aug 2019
First submitted
10 Apr 2017
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pivato CA, Mincione G, Gramss L, Pacchioni A, Piccolo R, Musto C, Sardella G, Indolfi C, Antonelli G, Regazzoli D, Paradies V, Reimers B, Condorelli G, Testa L, Briguori C, Stefanini G. Early oral anticoagulation monotherapy after PCI: Insights from the POEM trial. Am Heart J. 2026 Mar;293:107309. doi: 10.1016/j.ahj.2025.107309. Epub 2025 Nov 19.

    PubMed 41271123

  • Maurina M, Pivato CA, Kunadian V, Testa L, Briguori C, Pacchioni A, Latini AC, Cesani N, Piccolo R, Musto C, Sardella G, Indolfi C, Regazzoli D, Paradies V, Stefanini G. One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in women at high-bleeding risk: Insights from the POEM trial. Catheter Cardiovasc Interv. 2024 Nov;104(6):1129-1138. doi: 10.1002/ccd.31255. Epub 2024 Oct 3.

    PubMed 39359172

  • Popolo Rubbio A, Testa L, Pivato CA, Regazzoli D, Piccolo R, Esposito G, Musto C, Scalia L, Pacchioni A, Briguori C, Lucisano L, De Luca L, Conrotto F, Tartaglia F, Latini AC, Stankowski K, Chiarito M, Sardella G, Indolfi C, Bedogni F, Reimers B, Condorelli G, Stefanini GG. Application of the Academic Research Consortium High Bleeding Risk criteria in patients treated with coronary bioresorbable polymer everolimus-eluting stents: Insights from the POEM trial. Cardiovasc Revasc Med. 2024 Oct;67:77-83. doi: 10.1016/j.carrev.2024.04.022. Epub 2024 Apr 16.

    PubMed 38702260

  • Pivato CA, Reimers B, Testa L, Pacchioni A, Briguori C, Musto C, Esposito G, Piccolo R, Lucisano L, De Luca L, Conrotto F, De Marco A, Franzone A, Presbitero P, Ferrante G, Condorelli G, Paradies V, Sardella G, Indolfi C, Condorelli G, Stefanini GG. One-Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus-Eluting Stents in High Bleeding Risk Patients. J Am Heart Assoc. 2022 Mar 15;11(6):e023454. doi: 10.1161/JAHA.121.023454. Epub 2022 Feb 3.

    PubMed 35114814

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin and P2Y12 inhibitor in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Humanitas Hospital, Italy at 1 site in Italy.

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 16 inclusion and 6 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 7 Aug 2019. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03112707, which also lists 4 linked publications.

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 7 Aug 2019.

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