The Efficacy and Safety of Dabigatran Etexilate and Different Intensity Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- ischaemic stroke
研究概览
简要总结
The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of atrial fibrillation
- •Echocardiography confirmed a non-valvular heart disease
- •Age≥60 years
排除标准
- •Unable to cooperate with doctors
- •CHA2DS2-VASc<2
- •Life expectancy of less than 1 year
- •Rheumatic heart disease or dilated cardiomyopathy
- •History of artificial valve replacement surgery
- •Infectious endocarditis
- •Stroke or transient ischemic attack(TIA) within the last 6 months
- •Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding
- •Previous intolerance/allergy to warfarin or dabigatran etexilate
- •Blood pressure greater than 180/110 mmHg
- •Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times
- •Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min
- •Patient was receiving antiplatelet or anticoagulant therapy due to other reasons
研究组 & 干预措施
standard intensity warfarin group
standard intensity warfarin group， target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0)
干预措施: standard intensity warfarin (Drug)
low intensity warfarin group
low intensity warfarin group， target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2)
干预措施: low intensity warfarin (Drug)
dabigatran etexilate group
110mg dabigatran etexilate was administrated twice a day
干预措施: dabigatran etexilate (Drug)
结局指标
主要结局
ischaemic stroke
时间窗: 2 years
ischaemic stroke was defined as a blockage in an artery that supplies blood to the brain , resulting in a deficiency in blood flow and focal neurological deficit lasting \>24 hours.
major haemorrhage
时间窗: 2 years
Major haemorrhage was defined as intracranial hemorrhage, gastrointestinal bleeding, bleeding requiring hospitalization and surgical intervention, a reduction of hemoglobin by≥2 g/dL, requiring red blood cells transfusion ≥2 units.
次要结局
- all-cause mortality(2 years)
- myocardial infarction(2 years)
- pulmonary embolism(2 years)
- minor bleeding(2 years)
- cardiovascular death(2 years)