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History of Changes for Study: NCT03218787
XIENCE Short Dual Antiplatelet Therapy (DAPT) Study
Latest version (submitted October 8, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 13, 2017 None (earliest Version on record)
2 August 16, 2017 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 November 17, 2017 Contacts/Locations and Study Status
4 May 2, 2018 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Description, Study Status, Study Identification, Eligibility and Conditions
5 December 4, 2018 Contacts/Locations, Study Description, Study Status and Study Identification
6 August 27, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 August 13, 2020 Recruitment Status and Study Status
8 January 8, 2021 Study Status
9 August 25, 2021
Quality Control Review has not concluded Returned: September 20, 2021
Contacts/Locations, Study Status, Outcome Measures, Arms and Interventions, Document Section, Eligibility and Study Description
10 October 8, 2021 Adverse Events, Outcome Measures, Study Status and More Information
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Study NCT03218787
Submitted Date:  July 13, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 16-308
Brief Title: XIENCE Short Dual Antiplatelet Therapy (DAPT) Study
Official Title: XIENCE Short DAPT Study
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2017
Overall Status: Not yet recruiting
Study Start: July 2017
Primary Completion: June 2020 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: July 13, 2017
First Submitted that
Met QC Criteria:
July 13, 2017
First Posted: July 17, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
July 13, 2017
Last Update Posted: July 17, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
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.
Open or close this module Conditions
Conditions: Coronary Artery Lesions
Keywords: Coronary Artery Lesions
XIENCE
Dual Antiplatelet Therapy (DAPT)
Short term DAPT
High risk of bleeding
DES
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 2000 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • Dual antiplatelet therapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Composite Rate of all Death and all Myocardial Infarction (MI)
[ Time Frame: From 3 to 12 months ]

Secondary Outcome Measures:
1. All Bleedings (TIMI major, TIMI minor and TIMI minimal)
[ Time Frame: From 3 to 12 months ]

2. Stent Thrombosis (Definite and Probable) as Defined by ARC (Academic Research Consortium)
[ Time Frame: From 3 to 12 months ]

3. All Deaths, Cardiac Death, Vascular Death, and Non-cardiovascular
[ Time Frame: From 3 to 12 months ]

4. All MI and MI Attributed to Target Vessel (TV-MI)
[ Time Frame: From 3 to 12 months ]

5. Composite of Cardiac Death or MI
[ Time Frame: From 3 to 12 months ]

6. All Strokes, Ischemic Stroke and Hemorrhagic Stroke
[ Time Frame: From 3 to 12 months ]

7. Clinically-indicated Target Lesion Revascularization (CI-TLR)
[ Time Frame: From 3 to 12 months ]

8. Clinically-indicated Target Vessel Revascularization (CI-TVR)
[ Time Frame: From 3 to 12 months ]

9. Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI, CI-TLR)
[ Time Frame: From 3 to 12 months ]

10. Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI, CI-TVR)
[ Time Frame: From 3 to 12 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Bradley White
Telephone: 443.2812 Ext. 616
Email: bradley.white@av.abbott.com
Central Contact Backup: Vicky Morey
Email: vicky.morey@av.abbott.com
Study Officials: Weiying Zhao
Study Director
Abbott Medical Devices
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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