Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Palak Shah
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism)
研究概览
简要总结
Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
详细描述
This pilot study will be a prospective, randomized, controlled, open label, trial of HeartMate 3 (HM3) LVAD patients with 1:1 randomization to either apixaban or warfarin. All patients will be treated with aspirin 81 mg daily as per the LVAD manufacturer instructions for use (IFU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients implanted with a HeartMate 3 LVAD
- •Age 18 or greater and able to provide written informed consent
- •Females of childbearing age must agree to adequate contraception
排除标准
- •History of post-LVAD device thrombosis, stroke, or gastrointestinal bleeding
- •Patients who are bridge to transplant and a current UNOS status 1-3
- •Ongoing inotrope therapy after LVAD (e.g., milrinone, dobutamine, epinephrine)
- •Permanent right ventricular assist device at the time of LVAD implant
- •Patients with a mechanical heart valve
- •Patients with end-stage renal disease on dialysis
- •Pregnant patients
- •Known history of ischemic stroke, intracranial bleed, or neurosurgery within 3 months
- •Known history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system.
- •Recent (<48 hours) or planned spinal or epidural anesthesia or puncture
- •Prior history of known thrombophilia (e.g., factor V Leiden, prothrombin gene mutation, protein C or S deficiency, antithrombin 3 deficiency, hyperhomocysteinemia, antiphospholipid antibody syndrome) or indication for higher INR goal (>2.5) with warfarin.
- •Thrombolysis within the previous 7 days
- •Patients with an allergy or contraindication to aspirin, warfarin, or apixaban
- •Patients on antiplatelet therapy other than aspirin (e.g., clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline)
- •Patients on combined P-glycoprotein and strong CPY3A4 inhibitors or inducers (e.g., fluconazole, posaconazole, rifampin)
- •Known bleeding within the last 30 days requiring emergency room presentation or hospitalization
- •Known history of an inherited bleeding disorder (e.g., hemophilia, von Willebrand disease)
- •Patients with active bleeding or a hemoglobin < 8.0 g/dl
- •Total bilirubin > 2.0 mg/dl, shock liver, hepatic encephalopathy, or biopsy proven liver cirrhosis
- •INR > 2.0 not due to anticoagulation therapy
- •Platelet count <100,000 cells/mm3
研究组 & 干预措施
Apixaban
LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily.
干预措施: Apixaban (Drug)
Apixaban
LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily.
干预措施: LVAD implant (Device)
Warfarin
LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5
干预措施: Warfarin (Drug)
Warfarin
LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5
干预措施: LVAD implant (Device)
结局指标
主要结局
Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism)
时间窗: From enrollment to end of treatment at 24 weeks
Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)
次要结局
- Survival Free of Any Stroke(From enrollment to end of treatment at 24 weeks)
- Survival Free of Ischemic Stroke(From enrollment to end of treatment at 24 weeks)
- Survival Free of Hemorrhagic Stroke(From enrollment to end of treatment at 24 weeks)
- Survival Free of Device Thrombosis(From enrollment to end of treatment at 24 weeks)
- Cardiovascular Mortality(From enrollment to end of treatment at 24 weeks)
- Survival Free of Gastrointestinal Bleeding(From enrollment to end of treatment at 24 weeks)
- Survival Free of Major Non-gastrointestinal Bleeding(From enrollment to end of treatment at 24 weeks)
- All-cause Mortality(From enrollment to end of treatment at 24 weeks)
- Survival Free of Aortic Root Thrombus(From enrollment to end of treatment at 24 weeks)
研究者
Palak Shah
Medical Director, Mechanical Circulatory Support
Inova Health Care Services