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

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ClinicalTrials.gov Identifier: NCT03112707
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Giulio Stefanini, Humanitas Hospital, Italy

Tracking Information
First Submitted Date  ICMJE April 10, 2017
First Posted Date  ICMJE April 13, 2017
Last Update Posted Date August 8, 2018
Actual Study Start Date  ICMJE April 14, 2017
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Major Adverse Cardiac Events (MACE) [ Time Frame: 1 year ]
Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03112707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • All-cause death [ Time Frame: 30 days and 1 year ]
    All-cause death
  • Cardiac death [ Time Frame: 30 days and 1 year ]
    Cardiac death
  • Myocardial infarction [ Time Frame: 30 days and 1 year ]
    Myocardial infarction (defined according to III universal definition)
  • Stent thrombosis [ Time Frame: 30 days and 1 year ]
    Stent thrombosis (defined according to ARC criteria)
  • Target-vessel revascularization [ Time Frame: 30 days and 1 year ]
    Target-vessel revascularization (any and clinically driven)
  • Target-lesion revascularization [ Time Frame: 30 days and 1 year ]
    Target-lesion revascularization (any and clinically driven)
  • Major bleeding [ Time Frame: 30 days and 1 year ]
    Major bleeding (BARC 3 to 5)
  • Cerebrovascular event [ Time Frame: 30 days and 1 year ]
    Cerebrovascular event
  • Target-lesion failure [ Time Frame: 30 days and 1 year ]
    composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization
  • Patient oriented composite endpoint [ Time Frame: 30 days and 1 year ]
    Composite of any death, any MI, any revascularization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Aspirin
    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.
  • Drug: P2Y12 inhibitor
    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 Arms  ICMJE Experimental: Study arm
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.
Interventions:
  • Drug: Aspirin
  • Drug: P2Y12 inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
1023
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03112707
Other Study ID Numbers  ICMJE 012017POEM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Giulio Stefanini, Humanitas Hospital, Italy
Study Sponsor  ICMJE Humanitas Hospital, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Humanitas Hospital, Italy
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP