The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: standard intensity warfarin
* Drug: low intensity warfarin
* Drug: dabigatran etexilate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of atrial fibrillation Echocardiography confirmed a non-valvular heart disease Age≥60 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard intensity warfarin group<br>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) | Drug: standard intensity warfarin<br>* target international normalised ratio(INR) was 2.1-3.0<br>|
| Experimental: low intensity warfarin group<br>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) | Drug: low intensity warfarin<br>* target international normalised ratio(INR) was 1.7-2.2<br>|
| Active Comparator: dabigatran etexilate group<br>110mg dabigatran etexilate was administrated twice a day | Drug: dabigatran etexilate<br>* 110mg, twice a day, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischaemic stroke | 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. | 2 years | 
| major haemorrhage | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minor bleeding |  | 2 years | 
| myocardial infarction |  | 2 years | 
| pulmonary embolism |  | 2 years | 
| cardiovascular death |  | 2 years | 
| all-cause mortality |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Dabigatran, Warfarin, Anticoagulation, Elderly