The Effect and Safety of Different Intensity Anticoagulation Therapy in Elderly Patients With Non-valvular Atrial Fibrillation

Completed

Phase 4 Results N/A

Update History

22 May '12
Trial was updated to "Phase 4."
A location was updated in Nanjing.
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The overall status was removed for First Affiliated Hospital of Nanjing Medical University, Division of Geriatrics.
6 Oct '11
The description was updated.
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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.
Old
Atrial fibrillation is the commonest chronic arrhythmia in clinical practice, especially in octogenarians. Nonvalvular atrial ?brillation increases the risk of ischemic stroke by approximately 5-fold and these strokes result in higher mortality and disability. Warfarin is recommended as ?rst 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.
The eligibility criteria were updated.
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Inclusion Criteria: 1. Clinical diagnosis of atrial fibrillation 2. Echocardiography confirmed a non-valvular heart disease 3. Age≥75 years Exclusion Criteria: 1. Unable to cooperate with doctors 2. Life expectancy of less than 1 year 3. Rheumatic heart disease or dilated cardiomyopathy 4. History of artificial valve replacement surgery 5. Infectious endocarditis 6. Stroke or transient ischemic attack(TIA) within the last 6 months 7. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding 8. Previous intolerance/allergy to warfarin or aspirin 9. Blood pressure greater than 180/110 mmHg 10. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times 11. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min 12. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons
Old
Inclusion Criteria: 1. Clinical diagnosis of atrial fibrillation 2. Echocardiography confirmed a non-valvular heart disease 3. Age?75 years Exclusion Criteria: 1. Unable to cooperate with doctors 2. Life expectancy of less than 1 year 3. Rheumatic heart disease or dilated cardiomyopathy 4. History of artificial valve replacement surgery 5. Infectious endocarditis 6. Stroke or transient ischemic attack(TIA) within the last 6 months 7. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding 8. Previous intolerance/allergy to warfarin or aspirin 9. Blood pressure greater than 180/110 mmHg 10. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times 11. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min 12. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons