CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 870 enrolled
Drug / intervention
placebo + aspirin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01106534
NCT01106534Phase 4Completed
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XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)

Abbott Medical Devices·interventional·Posted Apr 20, 2010·Updated Nov 14, 2023

In Brief

A Phase 4 clinical trial evaluating placebo + aspirin, clopidogrel + aspirin OR prasugrel + aspirin, and 1 other intervention for Chronic Total Occlusion of Coronary Artery and 6 related conditions. Completed, enrolled 870 participants across 144 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
CountriesUnited States
CollaboratorsBaim Institute for Clinical Research, Bristol-Myers Squibb, Eli Lilly and Company, Daiichi Sankyo

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2010
Enrollment StartAug 1, 2009
Primary CompletionFeb 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 16.2 years ago

Interventions

placebo + aspirindrug

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.

clopidogrel + aspirin OR prasugrel + aspirindrug

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.

XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)device

XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.