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

Primary Purpose

Coronary Artery Disease, Acute Coronary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Aspirin
P2Y12 inhibitor
Sponsored by
Humanitas Hospital, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:

  1. Age ≥75 years
  2. Oral anticoagulation planned to continue after PCI
  3. Hemoglobin <11 g/l,
  4. Transfusion within 4 week before inclusion
  5. Platelet count <100'000
  6. Hospital admission for bleeding in previous 12 months
  7. Stroke in previous 12 months
  8. History of intracerebral hemorrhage
  9. Severe chronic liver disease
  10. Creatinine clearance <40 ml/min
  11. Cancer in previous 3 years
  12. Planned major surgery in next 12 months
  13. Glucocorticoids or NSAID planned for >30 days after PCI
  14. Expected non-adherence to >30 days of dual antiplatelet therapy

Exclusion Criteria:

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

Sites / Locations

  • Humanitas Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Major Adverse Cardiac Events (MACE)
Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis

Secondary Outcome Measures

All-cause death
All-cause death
Cardiac death
Cardiac death
Myocardial infarction
Myocardial infarction (defined according to III universal definition)
Stent thrombosis
Stent thrombosis (defined according to ARC criteria)
Target-vessel revascularization
Target-vessel revascularization (any and clinically driven)
Target-lesion revascularization
Target-lesion revascularization (any and clinically driven)
Major bleeding
Major bleeding (BARC 3 to 5)
Cerebrovascular event
Cerebrovascular event
Target-lesion failure
composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization
Patient oriented composite endpoint
Composite of any death, any MI, any revascularization

Full Information

First Posted
April 10, 2017
Last Updated
August 6, 2019
Sponsor
Humanitas Hospital, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03112707
Brief Title
Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT
Acronym
POEM
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Humanitas Hospital, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1023 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
P2Y12 inhibitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE)
Description
Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All-cause death
Description
All-cause death
Time Frame
30 days and 1 year
Title
Cardiac death
Description
Cardiac death
Time Frame
30 days and 1 year
Title
Myocardial infarction
Description
Myocardial infarction (defined according to III universal definition)
Time Frame
30 days and 1 year
Title
Stent thrombosis
Description
Stent thrombosis (defined according to ARC criteria)
Time Frame
30 days and 1 year
Title
Target-vessel revascularization
Description
Target-vessel revascularization (any and clinically driven)
Time Frame
30 days and 1 year
Title
Target-lesion revascularization
Description
Target-lesion revascularization (any and clinically driven)
Time Frame
30 days and 1 year
Title
Major bleeding
Description
Major bleeding (BARC 3 to 5)
Time Frame
30 days and 1 year
Title
Cerebrovascular event
Description
Cerebrovascular event
Time Frame
30 days and 1 year
Title
Target-lesion failure
Description
composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization
Time Frame
30 days and 1 year
Title
Patient oriented composite endpoint
Description
Composite of any death, any MI, any revascularization
Time Frame
30 days and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Stefanini, MD, PhD
Phone
0282247384
Email
giulio.stefanini@hunimed.eu
First Name & Middle Initial & Last Name & Degree
Giulio Stefanini, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bernhard Reimers, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35114814
Citation
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. Erratum In: J Am Heart Assoc. 2022 Aug 16;11(16):e020787.
Results Reference
derived

Learn more about this trial

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

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