Clinical efficacy and safety of non vitamin K anticoagulants compared to vitamin K anticoagulants in treatment of atrial fibrillation patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PT , INR Normal values indicate that patient is at lower risk of stroke .
研究概览
简要总结
STUDY SITE :
Department of cardiology , SRM Medical collage hospital and research centre , kattankulathur , kancheepuram , tamilnadu.
STUDY DURATION :
6 months period from November 2021 - April 2022
METHODOLOGY :
STUDY DESIGN :Prospective observational study
SAMPLE SIZE :
120 patients
GROUP A : 40 patients with warfarin 5 - 10 mg OD
GROUP B : 40 patients with rivaroxaban 10mg OD
GROUP C : 40 patients with dabigatran 110mg BD
VARIABLES TO BE STUDIED :
- PT
2.INR ratio
3.GARFIELD AF score
4.ECG
- CHAR’S Score
INCLUSION CRITERIA :
patient with ATRIAL FIBRILLATION
patients of both gender with age above 18 years
Left venticle Ejection fraction - <50%
EXCLUSION CRITERIA :
patient with anticoagulant therapy for a condition other than AF
Pregnant and lactating womens
patient with liver disease such as acute clinical hepatitis , chronic active hepatitis , cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Atrial fibrillation patients.
排除标准
- •Patient with anitcoagulant therapy for a condition other than AF n Pregnant and lactating women.
- •Patient with liver disease ( acute clinical hepatitis , chronic active hepatitis , cirrhosis ).
结局指标
主要结局
PT , INR Normal values indicate that patient is at lower risk of stroke .
时间窗: 3 months once
次要结局
- There is a significant risk of intracranial bleeding, GI bleeding in patients , GARFIELD - AF Score is used to asses this risk.(6 months once)