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XIENCE Short Dual Antiplatelet Therapy (DAPT) Study

This study is currently recruiting participants.
Verified August 2017 by Abbott Vascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT03218787
First Posted: July 17, 2017
Last Update Posted: August 18, 2017
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.
Information provided by (Responsible Party):
Abbott Vascular
  Purpose
The XIENCE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with any approved XIENCE family of Stent Systems.

Condition Intervention
Coronary Artery Lesions Device: XIENCE Drug: DAPT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XIENCE Short DAPT Study

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Composite Rate of all Death and all Myocardial Infarction (MI) [ Time Frame: From 3 to 12 months ]

Secondary Outcome Measures:
  • All Bleedings (TIMI major, TIMI minor and TIMI minimal) [ Time Frame: From 3 to 12 months ]
  • Stent Thrombosis (Definite and Probable) as Defined by ARC (Academic Research Consortium) [ Time Frame: From 3 to 12 months ]
  • All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular [ Time Frame: From 3 to 12 months ]
  • All MI and MI Attributed to Target Vessel (TV-MI) [ Time Frame: From 3 to 12 months ]
  • Composite of Cardiac Death or MI [ Time Frame: From 3 to 12 months ]
  • All Strokes, Ischemic Stroke and Hemorrhagic Stroke [ Time Frame: From 3 to 12 months ]
  • Clinically-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: From 3 to 12 months ]
  • Clinically-indicated Target Vessel Revascularization (CI-TVR) [ Time Frame: From 3 to 12 months ]
  • Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI, CI-TLR) [ Time Frame: From 3 to 12 months ]
  • Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI, CI-TVR) [ Time Frame: From 3 to 12 months ]

Estimated Enrollment: 2000
Actual Study Start Date: June 15, 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XIENCE + Short duration (3 months) of DAPT Device: XIENCE
Subjects who received XIENCE family stent systems will be included.
Drug: DAPT
3-month clear subjects who receive 3 months of DAPT and 12 months of aspirin after index procedure
Other Name: Dual antiplatelet therapy

Detailed Description:
This is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month DAPT in subjects at HBR undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (The XIENCE family stent systems include commercially approved XIENCE Xpedition Everolimus Eluting Coronary Stent System (EECSS), XIENCE Alpine EECSS or XIENCE PROX EECSS [OUS {Outside of United States} only]) of coronary drug-eluting stents. Approximately 2,000 subjects from approximately 150 sites globally will be enrolled, with at least 50% of subjects in the United States (US). Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 3-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 3 months after stenting and have been compliant with 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "3-month clear", and will discontinue P2Y12 receptor inhibitor and continued with aspirin monotherapy after 3-month follow-up. All registered subjects will be followed at 3, 6 and 12 months post index procedure. The data collected from this study will be compared with the historical control of HBR subjects.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

    1. ≥ 75 years of age.
    2. Clinical indication for chronic 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 Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure.
  4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 3 months, 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.
  2. Target lesion ≤ 32 mm in length by visual estimation.
  3. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
  4. Exclusive use of XIENCE family of stent systems during the index procedure.
  5. Target lesion has been treated successfully, which is defined as achievement of a final instent 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 or depression lasting > 5 minutes.

Exclusion Criteria:

  1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI) or non ST-segment elevation MI (NSTEMI), defined as acute ischemic symptoms occurring within 72 hours before index procedure and either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis (CK-MB [creatine kinase myocardial-band isoenzyme] or troponin T or I greater than the upper limit of normal; If CK-MB or troponin is not available, total CK (creatine kinase) > 2 times upper limit of normal).
  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. Subjects who had additional clinically significant lesion(s) in target or non-target vessel for which PCI may be required within 12 months after the index procedure.
  4. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
  5. Subject has a known left ventricular ejection fraction (LVEF) <30%.
  6. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use.
  7. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure.
  8. Subject with a current medical condition with a life expectancy of less than 12 months
  9. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.
  10. 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.
  11. 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.
  12. 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 total occluded lesion (TIMI flow 0).
  5. Target lesion contains thrombus as indicated in the angiographic images.
  6. Target lesion is implanted with overlapping stents, whether planned or for bailout.
  Contacts and Locations
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): NCT03218787


Contacts
Contact: Bradley White (616)443-2812 bradley.white@av.abbott.com
Contact: Vicky Morey vicky.morey@av.abbott.com

Locations
United States, Illinois
St. John's Hospital Recruiting
Springfield, Illinois, United States, 62769
Sponsors and Collaborators
Abbott Vascular
Investigators
Study Director: Weiying Zhao Abbott Vascular
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT03218787     History of Changes
Other Study ID Numbers: 16-308
First Submitted: July 13, 2017
First Posted: July 17, 2017
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Vascular:
Coronary Artery Lesions
XIENCE
Dual Antiplatelet Therapy (DAPT)
Short term DAPT
High risk of bleeding
DES