Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Drug: Aspirin Drug: P2Y12 inhibitor Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1023 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) [ Time Frame: 1 year ]
    Composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 30 days and 1 year ]
    All-cause death

  2. Cardiac death [ Time Frame: 30 days and 1 year ]
    Cardiac death

  3. Myocardial infarction [ Time Frame: 30 days and 1 year ]
    Myocardial infarction (defined according to III universal definition)

  4. Stent thrombosis [ Time Frame: 30 days and 1 year ]
    Stent thrombosis (defined according to ARC criteria)

  5. Target-vessel revascularization [ Time Frame: 30 days and 1 year ]
    Target-vessel revascularization (any and clinically driven)

  6. Target-lesion revascularization [ Time Frame: 30 days and 1 year ]
    Target-lesion revascularization (any and clinically driven)

  7. Major bleeding [ Time Frame: 30 days and 1 year ]
    Major bleeding (BARC 3 to 5)

  8. Cerebrovascular event [ Time Frame: 30 days and 1 year ]
    Cerebrovascular event

  9. Target-lesion failure [ Time Frame: 30 days and 1 year ]
    composite of cardiac death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization

  10. Patient oriented composite endpoint [ Time Frame: 30 days and 1 year ]
    Composite of any death, any MI, any revascularization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112707


Locations
Layout table for location information
Italy
Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Giulio Stefanini, MD, PhD    0282247384    giulio.stefanini@hunimed.eu   
Principal Investigator: Giulio Stefanini, MD, PhD         
Principal Investigator: Bernhard Reimers, MD         
Sponsors and Collaborators
Humanitas Hospital, Italy

Layout table for additonal information
Responsible Party: Giulio Stefanini, Assistant Professor of Cardiology, Humanitas Hospital, Italy
ClinicalTrials.gov Identifier: NCT03112707     History of Changes
Other Study ID Numbers: 012017POEM
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Everolimus
Sirolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors