drugset / Trial / NCT01106534
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
Phase 4
Completed
870 enrolled
Abbott Medical Devices
Baim Institute for Clinical Research · collabBristol-Myers Squibb · collabDaiichi Sankyo · collabEli Lilly and Company · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-08
- Primary completion
- 2015-02
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clopidogrel | Small molecule | — | — |
| Comparator | Prasugrel | Small molecule | — | — |
| Comparator | Aspirin | Small molecule | — | — |