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NCT01106534 · ClinicalTrials.gov registry record · Phase 4
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
A Phase 4 study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- Phase 4
- Development phase
- 870
- Enrollment target
NCT01106534 is a Phase 4 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 870 participants.
The verdict
NCT01106534, a Phase 4 study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 870 participants
- Enrollment target
Study 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.
Interventions
- DRUG placebo + aspirin
- DRUG clopidogrel + aspirin OR prasugrel + aspirin
- DEVICE XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 2009-08 |
| Est. Completion | 2015-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01106534
The ClinicalTrials.gov registry entry for NCT01106534 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 870 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo + aspirin is the first listed.
NCT01106534 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01106534 about?
NCT01106534 is a clinical study titled "XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort". 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 ther...
What is the current status of trial NCT01106534?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 870 participants. The study started on 2009-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01106534?
The interventions under investigation include: placebo + aspirin (DRUG), clopidogrel + aspirin OR prasugrel + aspirin (DRUG), XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) (DEVICE).
Who is sponsoring clinical trial NCT01106534?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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