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XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01106534
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Collaborators:
Baim Institute for Clinical Research
Bristol-Myers Squibb
Eli Lilly and Company
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE April 16, 2010
First Posted Date  ICMJE April 20, 2010
Results First Submitted Date  ICMJE July 31, 2015
Results First Posted Date  ICMJE June 28, 2016
Last Update Posted Date June 28, 2016
Study Start Date  ICMJE August 2009
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • Incidence of Composite of All Death, MI and Stroke (Defined as MACE) [ Time Frame: 12-33 months post-stent ]
  • Incidence of ARC Definite or Probable ST [ Time Frame: 12-33 months post-stent ]
  • Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) [ Time Frame: 12-33 months post-stent ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
  • Incidence of composite of all death, MI and stroke (defined as MACCE) [ Time Frame: 12-33 months post-stent ]
  • Incidence of ARC Definite or Probable ST [ Time Frame: 12-33 months post-stent ]
  • Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) [ Time Frame: 12-33 months post-stent ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • MACE for ITT Population [ Time Frame: 12 through 30 months ]
  • ST for ITT Population [ Time Frame: 12 through 30 months ]
  • Major Bleeding for ITT Population [ Time Frame: 12 through 30 months ]
  • MACE for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]
  • ST for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]
  • Major Bleeding for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
  • MACCE for ITT population [ Time Frame: 12 through 30 months ]
  • ST for ITT Population [ Time Frame: 12 through 30 months ]
  • Major bleed for ITT population [ Time Frame: 12 through 30 months ]
  • MACCE for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ]
  • ST for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ]
  • Major bleed for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Official Title  ICMJE XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)
Brief Summary

XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are

  • To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
  • To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.
Detailed Description

This prospective, multi-center, randomized, double-blind AV-DAPT study cohort is designed to collect data to support the FDA DAPT initiative. The protocol for AV-DAPT cohort is designed according to the HCRI-DAPT (NCT00977938) study protocol, Study IDE # G080186.

A total 8040 patients (5034 in initial enrollment phase and additional ~3000 patients in the second enrollment phase) enrolled in the XIENCE V USA (NCT00676520) had completed Phase I and were evaluated at 1 year.

These patients were transferred to the following cohorts in Phase II and followed-up for 1-5 years:

The long-term follow-up cohort of phase II (NCT01120379) consisted of 5020 patients from the first enrollment phase who were not transferred to the HCRI- DAPT study and remained in the study beyond 1 year.

Patients from the additional 3000 treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.

The remaining patients from the additional 3000 patients who did not participate in AV-DAPT cohort will be followed for the first year only. A study completion form will be filled out and the patients will not be followed beyond their 1 year visit.

The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Total Occlusion of Coronary Artery
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
Intervention  ICMJE
  • Drug: placebo + aspirin
    This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
  • Drug: clopidogrel + aspirin OR prasugrel + aspirin
    This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
    Other Name: Dual Antiplatelet Therapy
  • Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
    XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
Study Arms  ICMJE
  • Placebo Comparator: 12 month DAPT arm
    placebo + aspirin
    Interventions:
    • Drug: placebo + aspirin
    • Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
  • Active Comparator: 30 month DAPT arm
    clopidogrel + aspirin OR prasugrel + aspirin
    Interventions:
    • Drug: clopidogrel + aspirin OR prasugrel + aspirin
    • Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2011)
870
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2010)
1524
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who are enrolled into the XIENCE V USA Study Phase I
  • The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

  • The inability to obtain an informed consent is an exclusion criterion.

Patients must meet the following criteria to be eligible for randomization in the study:

  • Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear".
  • Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear".
  • Patient completes 1 year visit within ± 30 days window.

Patients will be excluded from randomization if any of the following criteria are met:

  • Pregnant women.
  • Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged.
  • PCI or cardiac surgery between 6 weeks post index procedure and randomization.
  • Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
  • Current medical condition with a life expectancy of less than 3 years.
  • Patients on warfarin or similar anticoagulant therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01106534
Other Study ID Numbers  ICMJE 06-374C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE
  • Baim Institute for Clinical Research
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Daiichi Sankyo, Inc.
Investigators  ICMJE
Principal Investigator: James Hermiller, MD Heart Center of Indianapolis
Principal Investigator: Mitch Krucoff, MD Duke University
PRS Account Abbott Medical Devices
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP