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XIENCE 28 USA Study

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ClinicalTrials.gov Identifier: NCT03815175
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS and XIENCE Sierra EECSS) of coronary drug-eluting stents.

Condition or disease Intervention/treatment Phase
Bleeding Disorder Ischemic Stroke Hemorrhagic Stroke Hematological Diseases Thrombocytopenia Coagulation Disorder Anemia Renal Insufficiency Coronary Artery Disease Device: XIENCE Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor) Not Applicable

Detailed Description:

The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be registered from approximately 50 sites in the United States and Canada. Subject registration is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28 Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XIENCE 28 USA Study
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: XIENCE
XIENCE + 1 month DAPT
Device: XIENCE
Subjects who received XIENCE family stent systems will be included.

Drug: DAPT (aspirin and/or P2Y12 receptor inhibitor)
"1-month clear" subjects will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.
Other Name: Dual antiplatelet therapy




Primary Outcome Measures :
  1. Composite rate of all death or all myocardial infarction (modified Academic Research Consortium [ARC]) [ Time Frame: From 1 to 6 months ]
  2. Composite rate of all death or all myocardial infarction (modified ARC) [ Time Frame: From 6 to 12 months ]
  3. Composite rate of all death or all myocardial infarction (modified ARC) [ Time Frame: From 1 to 12 months ]

Secondary Outcome Measures :
  1. Number of participants with major bleeding rate (Bleeding Academic Research Consortium [BARC] type 2-5) [ Time Frame: From 1 to 6 months ]

    The major secondary endpoint is major bleeding rate (BARC type 2-5) from 1 to 6 months.

    Major secondary analysis will be performed only if the primary hypothesis testing is successful.


  2. Number of participants with major bleeding rate (BARC type 2-5) [ Time Frame: From 6 to 12 months ]
  3. Number of participants with major bleeding rate (BARC type 2-5) [ Time Frame: From 1 to 12 months ]
  4. Number of participants with stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 6 months ]
  5. Number of participants with stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 6 to 12 months ]
  6. Number of participants with stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 12 months ]
  7. Number of all death, cardiac death, vascular death, non-cardiovascular death [ Time Frame: From 1 to 6 months ]
  8. Number of all death, cardiac death, vascular death, non-cardiovascular death [ Time Frame: From 6 to 12 months ]
  9. Number of all death, cardiac death, vascular death, non-cardiovascular death [ Time Frame: From 1 to 12 months ]
  10. Number of participants with all myocardial infarction (MI) and MI attributed to target vessel (TV-MI, modified ARC) [ Time Frame: From 1 to 6 months ]
  11. Number of participants with all MI and MI attributed to target vessel (TV-MI, modified ARC) [ Time Frame: From 6 to 12 months ]
  12. Number of participants with all MI and MI attributed to target vessel (TV-MI, modified ARC) [ Time Frame: From 1 to 12 months ]
  13. Composite of cardiac death or MI (modified ARC) [ Time Frame: From 1 to 6 months ]
  14. Composite of cardiac death or MI (modified ARC) [ Time Frame: From 6 to 12 months ]
  15. Composite of cardiac death or MI (modified ARC) [ Time Frame: From 1 to 12 months ]
  16. Composite of all death or all MI (modified ARC) [ Time Frame: From 1 to 6 months ]
  17. Composite of all death or all MI (modified ARC) [ Time Frame: From 6 to 12 months ]
  18. Composite of all death or all MI (modified ARC) [ Time Frame: From 1 to 12 months ]
  19. Number of participants with all stroke, ischemic stroke and hemorrhagic stroke [ Time Frame: From 1 to 6 months ]
  20. Number of participants with all stroke, ischemic stroke and hemorrhagic stroke [ Time Frame: From 6 to 12 months ]
  21. Number of participants with all stroke, ischemic stroke and hemorrhagic stroke [ Time Frame: From 1 to 12 months ]
  22. Number of participants with clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 1 to 6 months ]
  23. Number of participants with CI-TLR [ Time Frame: From 6 to 12 months ]
  24. Number of participants with CI-TLR [ Time Frame: From 1 to 12 months ]
  25. Number of participants with clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 1 to 6 months ]
  26. Number of participants with CI-TVR [ Time Frame: From 6 to 12 months ]
  27. Number of participants with CI-TVR [ Time Frame: From 1 to 12 months ]
  28. Number of participants with target lesion failure (TLF, composite of cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 6 months ]
  29. Number of participants with target lesion failure (TLF, composite of cardiac death, TV-MI and CI-TLR) [ Time Frame: From 6 to 12 months ]
  30. Number of participants with target lesion failure (TLF, composite of cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 12 months ]
  31. Number of participants with target vessel failure (TVF, composite of cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 6 months ]
  32. Number of participants with target vessel failure (TVF, composite of cardiac death, TV-MI and CI-TVR) [ Time Frame: From 6 to 12 months ]
  33. Number of participants with target vessel failure (TVF, composite of cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 12 months ]
  34. Number of participants with major bleeding (BARC type 3-5) [ Time Frame: From 1 to 6 months ]
  35. Major bleeding defined by the (BARC type 3-5) [ Time Frame: From 6 to 12 months ]
  36. Major bleeding defined by the (BARC type 3-5) [ Time Frame: From 1 to 12 months ]


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.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:

    1. ≥ 75 years of age.
    2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy
    3. History of major bleeding which required medical attention within 12 months of the index procedure.
    4. History of stroke (ischemic or hemorrhagic).
    5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
    6. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm3, or any known coagulation disorder associated with increased bleeding risk).
    7. Anemia with hemoglobin < 11g/dl.
  2. Subject must be at least 18 years of age.
  3. Subject must provide written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site prior to any trial related procedure.
  4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
  5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure, except for cases where subject is transferred to the XIENCE 90 study after the 1-month visit assessment

Angiographic Inclusion Criteria

  1. Up to three target lesions with a maximum of two target lesions per epicardial vessel. Note:

    • The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.
    • If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
  2. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
  3. Exclusive use of XIENCE family of stent systems during the index procedure.
  4. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria:

  1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
  2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
  4. Subject has a known left ventricular ejection fraction (LVEF) <30%.
  5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
  6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
  7. Subject with a current medical condition with a life expectancy of less than 12 months.
  8. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure. Transferring to the XIENCE 90 study will not be an exclusion criterion.
  9. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  11. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Angiographic Exclusion Criteria

  1. Target lesion is in a left main location.
  2. Target lesion is located within an arterial or saphenous vein graft.
  3. Target lesion is restenotic from a previous stent implantation.
  4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
  5. Target lesion is implanted with overlapping stents, whether planned or for bailout.

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): NCT03815175


Contacts
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Contact: Steve Peck 972-526-9665 steven.peck@abbott.com
Contact: Kunal Sampat 408-854-0746 kunal.sampat@abbott.com

Locations
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United States, Alabama
Heart Center Research, LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Karen Hensley    256-519-8203    khensley@theheartcenter.md   
Principal Investigator: Henry Chen, MD         
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
Contact: Elizabeth Persels    316-219-4112    elizabeth.persels@cckheart.com   
Principal Investigator: Aziz Maksoud, MD         
United States, South Carolina
Anmed Health Recruiting
Anderson, South Carolina, United States, 29621
Contact: Charlesa Davis    864-512-8734    charlesa.davis2@anmedhealth.org   
Principal Investigator: Brent McLaurin, MD         
United States, Texas
Austin Heart Recruiting
Austin, Texas, United States, 78756
Contact: Shannon Juarez    512-206-3603    Shannon.Juarez@HCAHealthcare.com   
Principal Investigator: Frank Zidar, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Roxana Mehran, MD Mount Sinai Medical Center,New York, NY

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03815175     History of Changes
Other Study ID Numbers: ABT-CIP-10271
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Abbott Medical Devices:
High Bleeding Risk (HBR)
Dual antiplatelet therapy (DAPT)
Drug eluting stent (DES)
XIENCE
Percutaneous coronary intervention (PCI)
Coronary Artery Disease

Additional relevant MeSH terms:
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Disease
Stroke
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hemorrhage
Thrombocytopenia
Renal Insufficiency
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Blood Platelet Disorders
Kidney Diseases
Urologic Diseases
Hemorrhagic Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents