XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)
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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 Total Occlusion of Coronary Artery Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis |
Drug: placebo + aspirin Drug: clopidogrel + aspirin OR prasugrel + aspirin Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) |
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) |
- Incidence of Composite of All Death, MI and Stroke (Defined as MACE) [ 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 ]
- MACE 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 Bleeding for ITT Population [ Time Frame: 12 through 30 months ] [ Designated as safety issue: Yes ]
- MACE for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]
- ST for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ] [ Designated as safety issue: Yes ]
- Major Bleeding for 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 |
| Study Completion Date: | July 2015 |
| Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 12 month DAPT arm
placebo + aspirin
|
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.
Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
|
|
Active Comparator: 30 month DAPT arm
clopidogrel + aspirin OR prasugrel + 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.
Other Name: Dual Antiplatelet Therapy
Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
|
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 (NCT00977938) study protocol, Study IDE # G080186.
A total 8040 patients (5034 in initial enrollment phase and additional ~3000 patients in the second enrollment phase) enrolled in the XIENCE V USA (NCT00676520) had completed Phase I and were evaluated at 1 year.
These patients were transferred to the following cohorts in Phase II and followed-up for 1-5 years:
The long-term follow-up cohort of phase II (NCT01120379) consisted of 5020 patients from the first enrollment phase who were not transferred to the HCRI- DAPT study and remained in the study beyond 1 year.
Patients from the additional 3000 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 AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. 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 3000 patients who did 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.
The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01106534
Show 144 Study Locations
| Principal Investigator: | James Hermiller, MD | Heart Center of Indianapolis |
| Principal Investigator: | Mitch Krucoff, MD | Duke University |
More Information
| Responsible Party: | Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT01106534 History of Changes |
| Other Study ID Numbers: | 06-374C |
| Study First Received: | April 16, 2010 |
| Results First Received: | July 31, 2015 |
| Last Updated: | May 12, 2016 |
| 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 Stenosis Coronary Restenosis Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes Clopidogrel Prasugrel Hydrochloride Aspirin |
Everolimus Sirolimus Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016