A Phase 4 interventional study of placebo + aspirin and clopidogrel + aspirin OR prasugrel + aspirin in Chronic Total Occlusion of Coronary Artery, Vascular Disease and Myocardial Ischemia, sponsored by Abbott Medical Devices. Completed at 144 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Abbott Medical Devices · Phase 4, Interventional, and Treatment
XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 870 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients must meet the following criteria to be eligible for randomization in the study:
Patients will be excluded from randomization if any of the following criteria are met:
placebo + aspirin
Drug: placebo + aspirin · Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
clopidogrel + aspirin OR prasugrel + aspirin
Drug: clopidogrel + aspirin OR prasugrel + aspirin · Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
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.
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.
Also known as: Dual Antiplatelet Therapy
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
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
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
Additional 3000 patients were enrolled in the second enrollment phase and had completed phase I at 1 year. In phase II, 870 patients from these were transferred to AV-DAPT cohort and followed from 1 year to 33 months, and the remaining who did not participate in AV-DAPT cohort will be followed for the first year only.
| Milestone | Second Enrollment Phase of XIENCE V® USA |
|---|---|
| Started | 2997 |
| Completed | 2960 |
| Not completed | 37 |
| Withdrew: Withdrawal by subject | 18 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Death | 16 |
| Withdrew: Physician decision | 1 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Second Enrollment Phase of XIENCE V® USA | — | — | — |
Baseline characteristics are provided for 2997 patients recruited in the second enrollment phase.
| Age, Continuous(years) | Second Enrollment Phase of XIENCE V® USA |
|---|---|
| Mean | 64.27 ± 10.39 |
| Age, Customized(participants) | Second Enrollment Phase of XIENCE V® USA |
|---|---|
| < 65 years | 1587 |
| >= 65 to < 75 years | 922 |
| >= 75 years | 488 |
| Sex: Female, Male(Participants) | Second Enrollment Phase of XIENCE V® USA |
|---|---|
| Female | 870 |
| Male | 2127 |
| Race/Ethnicity, Customized(participants) | Second Enrollment Phase of XIENCE V® USA |
|---|---|
| American Indian or Alaskan Native | 23 |
| Asian | 49 |
| Black or African Heritage | 231 |
| Native Hawaiian or Pacific Islander | 7 |
| White | 2577 |
| Hispanic or Latino | 117 |
| Other | 15 |
Showing the first 100 of 144 sites.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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