NCT03112707

Brief 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,023

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2017

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 14, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

April 10, 2017

Last Update Submit

August 6, 2019

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events (MACE)

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

    1 year

Secondary Outcomes (10)

  • All-cause death

    30 days and 1 year

  • Cardiac death

    30 days and 1 year

  • Myocardial infarction

    30 days and 1 year

  • Stent thrombosis

    30 days and 1 year

  • Target-vessel revascularization

    30 days and 1 year

  • +5 more secondary outcomes

Study Arms (1)

Study arm

EXPERIMENTAL

1023 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.

Drug: AspirinDrug: P2Y12 inhibitor

Interventions

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.

Study arm
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 arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 41271123DERIVED

  • 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.

    PMID: 39359172DERIVED

  • 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.

    PMID: 35114814DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Cardiology

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

April 14, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)