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XIENCE 28 Global Study

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ClinicalTrials.gov Identifier: NCT03355742
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Brief Summary:
XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the 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, XIENCE PROX EECSS, or XIENCE Sierra EECSS of coronary drug-eluting stents

Condition or disease Intervention/treatment Phase
Bleeding Disorder Stroke, Ischemic Stroke Hemorrhagic Hematological Disease Thrombocytopenia Coagulation Disorder Anemia Renal Insufficiency Coronary Artery Disease Device: XIENCE Drug: DAPT Not Applicable

Detailed Description:

The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. Approximately 800 subjects from approximately 50 sites globally will be registered in this trial. 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 and continue with aspirin monotherapy after 1-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 Global Study will be compared with the historical control of HBR subjects.


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 Global Study
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

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

Drug: DAPT
1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Other Name: Dual antiplatelet therapy




Primary Outcome Measures :
  1. Net Adverse Clinical Endpoint (NACE): Composite Rate of all-cause death and all myocardial infarction (MI), stent thrombosis, stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) [ Time Frame: From 1 to 6 months ]

Secondary Outcome Measures :
  1. Net Adverse Clinical Endpoint (NACE): Composite Rate of all-cause death and all myocardial infarction (MI), stent thrombosis, stroke or major bleeding (BARC type 2-5) [ Time Frame: From 1 to 12 months ]
  2. Net Adverse Clinical Endpoint (NACE): Composite Rate of all-cause death and all myocardial infarction (MI), stent thrombosis, stroke or major bleeding (BARC type 2-5) [ Time Frame: From 6 to 12 months ]
  3. Stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 6 months ]
  4. Stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 6 to 12 months ]
  5. Stent thrombosis (ARC definite/probable, ARC definite) [ Time Frame: From 1 to 12 months ]
  6. All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular death [ Time Frame: From 1 to 6 months ]
  7. All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular death [ Time Frame: From 6 to 12 months ]
  8. All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular death [ Time Frame: From 1 to 12 months ]
  9. All MI and MI Attributed to Target Vessel (TV-MI) [ Time Frame: From 1 to 6 months ]
  10. All MI and MI Attributed to Target Vessel (TV-MI) [ Time Frame: From 6 to 12 months ]
  11. All MI and MI Attributed to Target Vessel (TV-MI) [ Time Frame: From 1 to 12 months ]
  12. Composite of Cardiac death or MI [ Time Frame: From 1 to 6 months ]
  13. Composite of Cardiac death or MI [ Time Frame: From 6 to 12 months ]
  14. Composite of Cardiac death or MI [ Time Frame: From 1 to 12 months ]
  15. Composite of all death or all MI [ Time Frame: From 1 to 6 months ]
  16. Composite of all death or all MI [ Time Frame: From 6 to 12 months ]
  17. Composite of all death or all MI [ Time Frame: From 1 to 12 months ]
  18. All stroke, Ischemic stroke and Hemorrhagic stroke [ Time Frame: From 1 to 6 months ]
  19. All stroke, Ischemic stroke and Hemorrhagic stroke [ Time Frame: From 6 to 12 months ]
  20. All stroke, Ischemic stroke and Hemorrhagic stroke [ Time Frame: From 1 to 12 months ]
  21. Clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 1 to 6 months ]
  22. Clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 6 to 12 months ]
  23. Clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 1 to 12 months ]
  24. Clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 1 to 6 months ]
  25. Clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 6 to 12 months ]
  26. Clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 1 to 12 months ]
  27. Target lesion failure (TLF, composite of Cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 6 months ]
  28. Target lesion failure (TLF, composite of Cardiac death, TV-MI and CI-TLR) [ Time Frame: From 6 to 12 months ]
  29. Target lesion failure (TLF, composite of Cardiac death, TV-MI and CI-TLR) [ Time Frame: From 1 to 12 months ]
  30. Target vessel failure (TVF, composite of Cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 6 months ]
  31. Target vessel failure (TVF, composite of Cardiac death, TV-MI and CI-TVR) [ Time Frame: From 6 to 12 months ]
  32. Target vessel failure (TVF, composite of Cardiac death, TV-MI and CI-TVR) [ Time Frame: From 1 to 12 months ]
  33. Bleeding defined by the BARC type 2-5 and type 3-5 [ Time Frame: From 1 to 6 months ]
  34. Bleeding defined by the BARC type 2-5 and type 3-5 [ Time Frame: From 6 to 12 months ]
  35. Bleeding defined by the BARC type 2-5 and type 3-5 [ Time Frame: From 1 to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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. Subjects ≥ 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/mm^3, 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 or a legally authorized representative must provide written informed consent as approved by the Ethics Committee (EC) 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.

Angiographic Inclusion Criteria

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

    1. 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.
    2. 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 thrombolysis in myocardial infarction (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.
  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.

    Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population

  10. Subject is part of a vulnerable population, defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
  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): NCT03355742


Contacts
Contact: Mariah Tackett 4088453000 MTackett@sjm.com

Locations
Belgium
Onze-Lieve-Vrouwziekenhuis Campus Aalst Recruiting
Aalst, East Flanders, Belgium, 9300
Netherlands
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Friesland, Netherlands, 8934 AD
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Roxana Mehran, MD The Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine
Principal Investigator: Marco Valgimigli, MD Bern University Hospital

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT03355742     History of Changes
Other Study ID Numbers: 17-311
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Abbott Vascular:
XIENCE
High bleeding risk (HBR)
Dual antiplatelet therapy (DAPT)
Coronary Artery Disease
Drug eluting stent (DES)

Additional relevant MeSH terms:
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