XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Status: | Completed |
---|---|
Conditions: | Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 10/14/2017 |
Start Date: | August 2009 |
End Date: | July 2015 |
XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)
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.
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.
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.
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.
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.
We found this trial at
144
sites
110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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University of Cincinnati Medical Center Opening in 1823 as the country
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University of Southern California The University of Southern California is one of the world’s leading...
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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22 Saint Paul Drive
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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