Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported with a Left Ventricular Assist Device
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of survival free patients of any major hemocompatibility related adverse events.
研究概览
简要总结
Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes vitamin K antagonist (VKA), is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.
This clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.
详细描述
Objective: To study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure who are chronically supported with the HeartMate 3 LVAD.
Hypothesis: The withdrawal of aspirin from the antithrombotic regimen of HeartMate3 LVAD patients will not adversely affect safety and efficacy and may reduce non-surgical bleeding.
Clinical Investigation Design: This is a prospective, randomized, controlled clinical investigation of advanced heart failure patients who are chronically supported with the HeartMate 3 LVAD. The study will compare two different antithrombotic regimens: VKA with aspirin versus VKA without aspirin.
End points:
Primary end point:
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
- None
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
- •Participant will have HeartMate3 LVAD implanted > 3 months before enrollment.
- •>18 years old
- •Treated with aspirin and VKA
- •Participant must provide written informed consent prior to any clinical investigation-related procedure
排除标准
- •Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent)
- •Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- •Pregnant and on appropriate contraception
研究组 & 干预措施
Warfarin without Aspirin
Participants will only take Warfarin.
干预措施: Warfarin (Drug)
Warfarin and Aspirin
This is the control arm. Participants will take Warfarin and aspirin, which is the standard of care.
干预措施: Aspirin (Drug)
Warfarin and Aspirin
This is the control arm. Participants will take Warfarin and aspirin, which is the standard of care.
干预措施: Warfarin (Drug)
结局指标
主要结局
Number of survival free patients of any major hemocompatibility related adverse events.
时间窗: 1 year post implant
A Major Hemocompatibility Related Adverse Event is defined as: Stroke, Pump Thrombosis (suspected or confirmed), major non-surgical Bleeding (moderate or severe) (including intracranial bleeds that do not meet the stroke definition), Arterial Peripheral Thromboembolism. The events will be recorded and tallied per patient.
次要结局
- Number of Non-surgical Major Hemorrhagic Events(1 year)
- Number of Non-surgical Major Thrombotic Events(1 year)
- Survival Rate(1 year)
- Stroke Incidence(1 year)
- Pump Thrombosis Incidence(1 year)
- Bleeding Incidence(1 year)
研究者
Nir Uriel
Professor of Cardiology (in Medicine)
Columbia University