Monitor System for the Safety of Dabigatran Treatment (MISSION-AF)
2019年9月19日 更新者：Second Affiliated Hospital of Nanchang University
A Monitor System for the Safety of Dabigatran Anticoagulation Treatment in Nonvalvular Atrial Fibrillation
The purpose of this study is to determine whether dabigatran is associated with higher risk of bleeding in Asia area especially in China clinical practice and whether it need to set up a monitor system.
研究概览
地位
完全的
条件
详细说明
Dabigatran is administered in a fixed does without laboratory monitoring and is being compared with warfarin (international normalized ratio, but only hundreds of evidence from Asia events in several multicenter, prospective, randomized trails.
It remains unclear that whether Dabigatran is safety in China clinical practice and no need of monitor test.
We identified participants as those diagnosed as having nonvalved atrial fibrillation, and who initiated dabigatran after diagnosis.We followed up each individual from the first prescription of dabigatran until discontinued use or switch of anticoagulants, death, or other outcomes or until one year later.
We categorized bleeding events as major and minor events according to anatomical position.
We defined time to bleeding as days between the first dabigatran prescription and the date of the bleeding event.
We analyzed the time to the first bleeding event, as well as the time to the first major hemorrhage, intracranial hemorrhage, gastrointestinal bleeding, hematuria, vaginal bleeding, hemarthrosis, hemoptysis, and epistaxis.
研究类型
观察性的
注册 (实际的)
1496
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Jiangxi
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Nanchang、Jiangxi、中国、330006
- The second hospital affillated of Nanchang University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
We identified participants as those diagnosed as having artrial fibrillation, and who initiated dabigatran after diagnosis.
The diagnosis of AF was defined as having inpatient or outpatient claims with primary or secondary International Classification of Diseases, Ninth Revision(ICD-9), code427.31.12.
The CHADS2-VAS score is calculated as the sum of all points for a given patient and need >=1.
A history of previous stroke or transient ischemic attack is assigned 2 points; congestive heart failure, hypertension, age of 75 years or older, and diabetes are each assigned 1 point.
描述
Inclusion Criteria:
- Age>18 y at entry
- AF documented as follows: The patients has a symptomatic episode of paroxysmal or persistent AF documented by 12-lead ECG, rhythm strip, pacemaker/implantable cardioverter-defibrillator electrogram, or Holter ECG
- In addition to documented AF, patients must have ≥1 CHADS2-VAS scores
- We identified participants as those diagnosed as having AF, and who initiated dabigatran after diagnosis
- Written, informed consent
Exclusion Criteria:
- History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
- Severe, disabling stroke, or any stroke within the previous 14d
- Acute coronary syndrome within 1 year in AF patients
Conditions associated with an increased risk of bleeding
- Major surgery in the previous month
- History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
- Gastrointestinal hemorrhage or hematuria
- Severe renal impairment (estimated creatinine clearace≤30ml/min)
- Severe liver dysfunction
- Alcohol abuse or drug addiction
- Patients who have received an investigational drug at this time
- Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trail
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
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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Major bleeding events
大体时间：up to 12 months (or) years
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Any of the following events happened: intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for gastrointestinal, hematuria,or NOS hemorrhage
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up to 12 months (or) years
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Minor bleeding events
大体时间：up to 12 months (or) years
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Any of the following events happened: epistaxis, hemoptysis, vaginal hemorrhage, hemarthrosis and any outpatient claim for hematuria, gastrointestinal, and NOS hemorrhage.
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up to 12 months (or) years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xiao s Cheng, MD,PhD、The second hospital affillated of Nanchang University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, Zhu J, Jansky P, Sigamani A, Morillo CA, Liu L, Damasceno A, Grinvalds A, Nakamya J, Reilly PA, Keltai K, Van Gelder IC, Yusufali AH, Watanabe E, Wallentin L, Connolly SJ, Yusuf S; RE-LY Atrial Fibrillation Registry Investigators. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry. Circulation. 2014 Apr 15;129(15):1568-76. doi: 10.1161/CIRCULATIONAHA.113.005451. Epub 2014 Jan 24. Erratum In: Circulation. 2015 Feb 17;131(7):e352.
- Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009 May;157(5):805-10, 810.e1-2. doi: 10.1016/j.ahj.2009.02.005.
- Steinberg BA, Piccini JP. Anticoagulation in atrial fibrillation. BMJ. 2014 Apr 14;348:g2116. doi: 10.1136/bmj.g2116.
- Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015 Jan 13;131(2):157-64. doi: 10.1161/CIRCULATIONAHA.114.012061. Epub 2014 Oct 30.
- Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW, Ezekowitz MD, Nehmiz G, Wang S, Wallentin L; RE-LY Investigators. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol. 2014 Feb 4;63(4):321-8. doi: 10.1016/j.jacc.2013.07.104. Epub 2013 Sep 27.
- Zhou W, Wang T, Zhu LJ, Wen MH, Hu LH, Huang X, You CJ, Li JX, Wu YQ, Wu QH, Bao HH, Cheng XS. Peripheral leukocyte count and risk of bleeding in patients with non-valvular atrial fibrillation taking dabigatran: a real-world study. Chin Med J (Engl). 2019 Sep 20;132(18):2150-2156. doi: 10.1097/CM9.0000000000000423.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年3月22日
初级完成 (实际的)
2018年3月1日
研究完成 (实际的)
2018年4月18日
研究注册日期
首次提交
2015年3月25日
首先提交符合 QC 标准的
2015年4月7日
首次发布 (估计)
2015年4月10日
研究记录更新
最后更新发布 (实际的)
2019年9月23日
上次提交的符合 QC 标准的更新
2019年9月19日
最后验证
2019年9月1日
更多信息
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.