The Effect and Safety of Different Intensity Anticoagulation Therapy in Elderly Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- major haemorrhage
研究概览
简要总结
Current guidelines recommend standard warfarin anticoagulation international normalized ratio (INR) goal of 2.0-3.0 in adults with non valvular atrial fibrillation (NVAF). The investigators hypothesized that low-intensity warfarin (INR 1.5-2.0) has the same effectiveness and better security in elderly patients (>75) with NVAF.
详细描述
Atrial fibrillation is the commonest chronic arrhythmia in clinical practice, especially in octogenarians. Nonvalvular atrial fibrillation increases the risk of ischemic stroke by approximately 5-fold and these strokes result in higher mortality and disability. Warfarin is recommended as first line anticoagulation treatment in patients with NVAF who are at moderate or high risk of stroke,while antiplatelet agents, such as aspirin, give a more convenient but less effective alternative in the prevention of ischemic stroke and are recommended in low risk patients.Current guideline about warfarin anticoagulation therapy recommend that target INR value must be maintained between 2.0 and 3.0,which not only reduces the frequency of ischaemic stroke but also its low incidence of major bleeding. However, the current status of anticoagulation therapy for elderly Chinese AF patients, particularly in aged over 80 years, is not clear. The purpose of the present study was to test the hypothesis that an INR target of 1.5-2.0 can provide the same efficacy and better safety as compare with a standard target of 2.0-3.0 in patients over 75 with NVAF.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 94 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of atrial fibrillation
- •Echocardiography confirmed a non-valvular heart disease
- •Age≥75 years
排除标准
- •Unable to cooperate with doctors
- •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 aspirin
- •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
Eligible 80 patients(83.14±4.05,33.0%)with chronic NVAF were randomly assigned to this group and the target international normalised ratio(INR) was 2.1-3.0
干预措施: Warfarin (Drug)
low intensity warfarin group
Eligible 81 patients(84.0±4.71,33.5%)with chronic NVAF were randomly assigned to this group and the target international normalised ratio(INR) was 1.5-2.0
干预措施: Warfarin (Drug)
aspirin group
Eligible 81 patients(83.4±5.13,33.5%)with chronic NVAF were randomly assigned to this group and 100mg aspirin was administrated every day
干预措施: aspirin (Drug)
结局指标
主要结局
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. Follow-up study visits were scheduled for once a week in the first month and then every 3 months. The number and results of INR tests, liver and kidney function tests were recorded. In addition, the number of bleeding events was recorded.
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. Follow-up study visits were scheduled for once a week in the first month and then every 3 months. The number and results of INR tests, liver and kidney function tests were recorded. In addition, the number of ischaemic stroke was recorded.
次要结局
- minor bleeding(2.5years)
- myocardial infarction(2.5 years)
- deep vein thrombosis(2.5 years)
- pulmonary embolism(2.5 years)
- cardiovascular death(2.5 years)
研究者
Wu Jun
First Affiliated Hospital of Nanjing Medical University
Nanjing Medical University