Clinical trial NCT01438580: The Effect and Safety of Different Intensity Anticoagulation Therapy in Elderly Patients With Non-valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial ﬁbrillation
stroke
warfarin
aspirin
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 260
Sex: ALL
Minimum age (years): 75
Maximum age (years): 94
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: major haemorrhage
timeFrame: 2 years
measure: ischaemic stroke
timeFrame: 2 years
Secondary outcomes:
measure: minor bleeding
timeFrame: 2.5years
measure: myocardial infarction
timeFrame: 2.5 years
measure: deep vein thrombosis
timeFrame: 2.5 years
measure: pulmonary embolism
timeFrame: 2.5 years
measure: cardiovascular death
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University, Division of Geriatrics
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Guo Yan, doctor
role: STUDY_DIRECTOR
References:
citation: Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available.