XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

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.

Conditions

• Chronic Total Occlusion of Coronary Artery
• Vascular Disease
• Myocardial Ischemia
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Artery Disease
• Coronary Restenosis

Interventions

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.

DEVICE

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

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

Sponsors & Collaborators

• Baim Institute for Clinical Research

  collaborator OTHER

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Eli Lilly and Company

  collaborator INDUSTRY

• Daiichi Sankyo

  collaborator INDUSTRY

• Abbott Medical Devices

  lead INDUSTRY

Principal Investigators

• James Hermiller, MD · Heart Center of Indianapolis

• Mitch Krucoff, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2015-02-28

Completion

2015-07-31

Countries

• United States

Study Locations