XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Coronary Occlusion Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis	Drug: Thienopyridine (clopidogrel or prasugrel)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Vascular Diseases

Drug Information available for: Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

Incidence of composite of all death, MI and stroke (defined as MACCE) [ Time Frame: 12-33 months post-stent ] [ Designated as safety issue: Yes ]
Incidence of ARC definite or probable ST [ Time Frame: 12-33 months post-stent ] [ Designated as safety issue: Yes ]
Major bleeding (GUSTO classification, severe and moderate bleeding combined) [ Time Frame: 12-33 months post-stent ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

MACCE for ITT population [ Time Frame: 12 through 30 months ] [ Designated as safety issue: Yes ]
ST for ITT population [ Time Frame: 12 through 30 months ] [ Designated as safety issue: Yes ]
Major bleed for ITT population [ Time Frame: 12 through 30 months ] [ Designated as safety issue: Yes ]
MACCE for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]
ST for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]
Major bleed for on treatment population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]

Enrollment:	870
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 12m DAPT arm placebo for clopidogrel + aspirin OR placebo for prasugrel + aspirin	Drug: Thienopyridine (clopidogrel or prasugrel) Compare 12 and 30 months of DAPT treatment in patients undergoing PCI with stent placement
Active Comparator: 30 month DAPT arm clopidogrel + aspirin OR prasugrel + aspirin	Drug: Thienopyridine (clopidogrel or prasugrel) Compare 12 and 30 months of DAPT treatment in patients undergoing PCI with stent placement

Detailed Description:

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 study protocol, Study IDE # G080186. Patients from the additional 3,000 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 cohort. Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized to 18 months of active treatment with thienopyridines or placebo 12 months after index procedure. 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 3,000 patients who do 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are enrolled into the XIENCE V USA Study Phase I
The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion Criteria:

The inability to obtain an informed consent is an exclusion criterion.

Patients must meet the following criteria to be eligible for randomization in the study:

Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear".
Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear".
Patient completes 1 year visit within ± 30 days window.

Patients will be excluded from randomization if any of the following criteria are met:

Pregnant women.
Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged.
PCI or cardiac surgery between 6 weeks post index procedure and randomization.
Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
Current medical condition with a life expectancy of less than 3 years.
Patients on warfarin or similar anticoagulant therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106534

Show 144 Study Locations

Sponsors and Collaborators

Abbott Vascular

Harvard Clinical Research Institute

Bristol-Myers Squibb

Eli Lilly and Company

Daiichi Sankyo Inc.

Investigators

Principal Investigator:	James Hermiller, MD	Heart Center of Indianapolis
Principal Investigator:	Mitch Krucoff, MD	Duke University

More Information

No publications provided

Responsible Party:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT01106534 History of Changes
Other Study ID Numbers:	06-374C
Study First Received:	April 16, 2010
Last Updated:	September 17, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott Vascular:

drug eluting stents
Stents
Angioplasty
Stent thrombosis
antiplatelet treatment

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Vascular Diseases
Coronary Occlusion
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

Clopidogrel
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013

XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)