利伐沙班与华法林治疗心脏手术后房颤 (NEW-AF)
新型口服抗凝剂与华法林治疗心脏手术后心房颤动的试验
研究概览
详细说明
新发心房颤动 (NOAF) 在心脏手术后很常见，发生在 20-30% 的术后患者中。 从历史上看，华法林维生素 K 拮抗剂疗法一直是 NOAF 患者预防中风和全身动脉血栓栓塞的首选治疗方法。 华法林抑制内在和外在凝血级联反应中涉及的维生素 K 依赖因子，从而减少全身凝血。 然而，华法林治疗面临许多挑战，包括延长滴定时间、繁琐的监测要求，在某些情况下还会增加出血风险。
与华法林相关的局限性可以通过使用新的口服抗凝剂 (NOAC) 来减轻，例如没有常规监测要求的利伐沙班。 利伐沙班是 Xa 因子的直接抑制剂，Xa 因子是内源性和外源性凝血级联反应的中心反应物。 对非手术房颤患者的研究表明，利伐沙班在预防卒中方面不劣于华法林，风险状况相似。 本研究旨在比较这两种药物用于治疗心脏手术后新发心房颤动的疗效、安全性和经济成本。
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 男性或女性 ≥ 18 岁
- 至少进行以下手术之一：冠状动脉旁路移植术、主动脉瓣修复术、二尖瓣修复术、非机械主动脉瓣置换术、这些手术的任意组合
- 两次或多次新发心房颤动（每次持续 > 20 分钟）或持续性心房颤动持续 > 24 小时（或在 24 小时间隔内持续 > 18 小时）
- 如果是育龄女性，请采取适当的避孕措施
排除标准：
- 心脏手术前已存在阵发性心房颤动
- 已有抗凝治疗适应症（包括但不限于肺栓塞、深静脉血栓、机械瓣膜）
- 未通过手术矫正的中度至重度二尖瓣狭窄
- 预先存在过敏研究药物
- 最近（< 1 年）或正在进行的怀孕（将在参加研究时对育龄妇女进行尿液妊娠试验）
- 手术前 1 个月内或术后开始研究药物前发生中风
- 研究药物开始前的术后出血事件
- 其他器官系统的严重功能障碍，包括 GFR < 30 ml/min、基线 INR > 1.7、肠梗阻或其他胃肠道病理阻碍吸收口服药物的能力，以及已知的凝血途径缺陷
- 术后需要非阿司匹林抗血小板治疗，并且在开始治疗性抗凝治疗时不能停药
- 患者服用的药物与研究药物有已知的主要相互作用，没有治疗替代品）
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：利伐沙班
利伐沙班：Xa 因子的直接抑制剂，Xa 因子是一种刺激凝血酶原形成凝血酶的酶（凝血级联的内在和外在方面的关键步骤） 剂型：Per Os（口服） 剂量和频率：每晚 20 毫克，随晚餐服用（无滴定要求）。 对于肾小球滤过率降低（GFR 在 15 ml/min 和 50 ml/min 之间）的患者，每晚随晚餐服用的剂量将减至 15 mg。 持续时间：30 天（术后心脏病学门诊就诊后可以继续） |
通过直接抑制 Xa 因子发挥作用的抗凝药物。 FDA 批准用于预防非瓣膜性心房颤动中风
其他名称：
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有源比较器：华法林
华法林：维生素 K 环氧还原酶复合物 1 的竞争性抑制剂，维生素 K 依赖性凝血因子激活途径中的一种重要酶 剂型：Per Os（口服） 剂量和频率：初始剂量为每晚 2 - 5 毫克，晚饭后 (QHS) 适当滴定至目标 INR 2.0 - 3.0（初始剂量基于体重、年龄、性别、合并症和并发药物）。 根据剂量和药物治疗方案的稳定性，将每天至每周检查 INR。 持续时间：30 天（术后心脏病学门诊就诊后可以继续） |
通过抑制维生素 K 依赖性凝血因子发挥作用的抗凝药物。
FDA 批准用于预防心房颤动中风
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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术后住院时间
大体时间：心脏手术后最多 6 个月
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离开手术室后住院天数
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心脏手术后最多 6 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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轻微出血
大体时间：从最初的术后住院出院后最多 30 天
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少量出血定义为输血 <= 2 个单位或服用研究药物后血红蛋白下降大于 3g/dL
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从最初的术后住院出院后最多 30 天
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Episode of Major Bleeding (Defined as the Occurrence of Any of Several Events Listed in the Description. No Specific Scale, Questionnaire or Instrument Will be Used)
大体时间：Up to 30 days after discharge from the initial postoperative hospitalization
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Major bleeding defined as re-operation or other therapeutic intervention for bleeding (including but not limited to colonoscopy, upper endoscopy and urologic procedures for hematuria), development of any intracranial bleeding, cessation of study drug for bleeding concerns, reversal of study drug for bleeding concerns and/or new transfusion requirement > 2 units of blood after drug administration
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Up to 30 days after discharge from the initial postoperative hospitalization
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Cerebrovascular Accident (CVA)
大体时间：Up to 30 days after discharge from the initial postoperative hospitalization
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Rates of cerebrovascular accident including stroke and transient ischemic attack (TIA)
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Up to 30 days after discharge from the initial postoperative hospitalization
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Other Systemic Embolism
大体时间：Up to 30 days after discharge from the initial postoperative hospitalization
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Rates of non-neurological systemic arterial embolism involving any organ system
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Up to 30 days after discharge from the initial postoperative hospitalization
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Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE)
大体时间：Up to 30 days after discharge from the initial postoperative hospitalization
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Occurrence of pathologic venous thrombo-embolism including DVT and PE
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Up to 30 days after discharge from the initial postoperative hospitalization
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Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
大体时间：Up to 30 days after discharge from the initial postoperative hospitalization
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Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences. |
Up to 30 days after discharge from the initial postoperative hospitalization
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Performance on the EUROQOL (EQ-5D) Quality of Life Instrument - VAS
大体时间：Up to 30 days after discharge from the initial postoperative hospitalization
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Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences. The visual analog scale is single answer between 0 and 100 representing the patient's perception of their health state. 0 represents the worst health imaginable and 100 represents the best. |
Up to 30 days after discharge from the initial postoperative hospitalization
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Average Score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2)
大体时间：Up to 30 days after discharge from the initial postoperative hospitalization
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Participants will be administered the PACT-Q2 questionnaire which is comprised of a convenience subscale and a satisfaction subscale. For the convenience subscale, each of 13 questions is answered on a 1-5 rating scale with higher numbers representing worse outcomes. A sub-scale score is generated by inverting the score from each element and calculating the sum. Range on the inverted scale is 13 - 65. Higher scores represent better outcomes. For the satisfaction subscale, each of 7 questions is answered on a 1-5 rating scale with higher numbers representing better outcomes. The total score on this subscale is generated by adding up scores from all elements. Range on this subscale is 7-35. Higher scores represent better outcomes. A composite score is generated by adding up scores from both subscales and recalibrating on a 0-100 scale by adding the scores together and applying the formula: COMPOSITE SCORE=100×(Sum-20)/80. Higher scores represent more favorable outcomes. |
Up to 30 days after discharge from the initial postoperative hospitalization
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合作者和调查者
调查人员
- 首席研究员：Asishana A Osho, MD, MPH、Massachusetts General Hospital
- 首席研究员：Thoralf M Sundt, MD、Massachusetts General Hospital
出版物和有用的链接
一般刊物
- Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
- Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.
- Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
- Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Suh E, Spiro TE, Barnathan ES, Raskob GE; MARINER Investigators. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med. 2018 Sep 20;379(12):1118-1127. doi: 10.1056/NEJMoa1805090. Epub 2018 Aug 26.
- Charlton B, Adeboyeje G, Barron JJ, Grady D, Shin J, Redberg RF. Length of hospitalization and mortality for bleeding during treatment with warfarin, dabigatran, or rivaroxaban. PLoS One. 2018 Mar 28;13(3):e0193912. doi: 10.1371/journal.pone.0193912. eCollection 2018.
- Megens MR, Churilov L, Thijs V. New-Onset Atrial Fibrillation After Coronary Artery Bypass Graft and Long-Term Risk of Stroke: A Meta-Analysis. J Am Heart Assoc. 2017 Dec 22;6(12):e007558. doi: 10.1161/JAHA.117.007558.
- Hawks MK, Bryce C. Rivaroxaban vs. Warfarin for Anticoagulation in Patients with Atrial Fibrillation Undergoing Ablation and Cardioversion. Am Fam Physician. 2016 Oct 1;94(7):Online. No abstract available.
- Gillinov AM, Bagiella E, Moskowitz AJ, Raiten JM, Groh MA, Bowdish ME, Ailawadi G, Kirkwood KA, Perrault LP, Parides MK, Smith RL 2nd, Kern JA, Dussault G, Hackmann AE, Jeffries NO, Miller MA, Taddei-Peters WC, Rose EA, Weisel RD, Williams DL, Mangusan RF, Argenziano M, Moquete EG, O'Sullivan KL, Pellerin M, Shah KJ, Gammie JS, Mayer ML, Voisine P, Gelijns AC, O'Gara PT, Mack MJ; CTSN. Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery. N Engl J Med. 2016 May 19;374(20):1911-21. doi: 10.1056/NEJMoa1602002. Epub 2016 Apr 4.
- Anderson E, Johnke K, Leedahl D, Glogoza M, Newman R, Dyke C. Novel oral anticoagulants vs warfarin for the management of postoperative atrial fibrillation: clinical outcomes and cost analysis. Am J Surg. 2015 Dec;210(6):1095-102; discussion 1102-3. doi: 10.1016/j.amjsurg.2015.07.005. Epub 2015 Sep 18.
- Osho AA, Moonsamy P, Ethridge BR, Leya GA, D'Alessandro DA, Jassar AS, Villavicencio MA, Melnitchouk SI, Tolis G, Langer NB, Funamoto M, Li SS, Colon KM, Mohan N, Locascio JJ, Lubitz SA, Akeju O, Sundt TM. Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants Versus Warfarin for Post Cardiac Surgery Atrial Fibrillation: The NEW-AF Trial. Ann Surg. 2022 Jul 1;276(1):200-204. doi: 10.1097/SLA.0000000000004459. Epub 2020 Sep 1.
- Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30.
- Butt JH, Xian Y, Peterson ED, Olsen PS, Rorth R, Gundlund A, Olesen JB, Gislason GH, Torp-Pedersen C, Kober L, Fosbol EL. Long-term Thromboembolic Risk in Patients With Postoperative Atrial Fibrillation After Coronary Artery Bypass Graft Surgery and Patients With Nonvalvular Atrial Fibrillation. JAMA Cardiol. 2018 May 1;3(5):417-424. doi: 10.1001/jamacardio.2018.0405.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2018P002307
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
利伐沙班的临床试验
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Science Valley Research Institute招聘中心血管疾病 | 外周动脉疾病 | 静脉thormboombolism | 血管外科手术患者患有垫 /颈动脉狭窄巴西