A Monitor System for the Safety of Dabigatran Anticoagulation Treatment in Nonvalvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,496
- 试验地点
- 1
- 主要终点
- Major bleeding events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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
排除标准
- •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
结局指标
主要结局
Major bleeding events
时间窗: up to 12 months (or) years
Any of the following events happened: intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for gastrointestinal, hematuria,or NOS hemorrhage
Minor bleeding events
时间窗: up to 12 months (or) years
Any of the following events happened: epistaxis, hemoptysis, vaginal hemorrhage, hemarthrosis and any outpatient claim for hematuria, gastrointestinal, and NOS hemorrhage.
次要结局
未报告次要终点