XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 870
- 试验地点
- 144
- 主要终点
- Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
12 month DAPT arm
placebo + aspirin
干预措施: placebo + aspirin (Drug)
12 month DAPT arm
placebo + aspirin
干预措施: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) (Device)
30 month DAPT arm
clopidogrel + aspirin OR prasugrel + aspirin
干预措施: clopidogrel + aspirin OR prasugrel + aspirin (Drug)
30 month DAPT arm
clopidogrel + aspirin OR prasugrel + aspirin
干预措施: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) (Device)
结局指标
主要结局
Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
时间窗: 12-33 months post-stent
Incidence of ARC Definite or Probable ST
时间窗: 12-33 months post-stent
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)
时间窗: 12-33 months post-stent
次要结局
- MACE for ITT Population(12 through 30 months)
- ST for ITT Population(12 through 30 months)
- Major Bleeding for ITT Population(12 through 30 months)
- MACE for Treatment Population(12 through 30 months and 12 through 33 months)
- ST for Treatment Population(12 through 30 months and 12 through 33 months)
- Major Bleeding for Treatment Population(12 through 30 months and 12 through 33 months)