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

NCT ID: NCT01438580

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-04-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Warfarin

Intervention Type: DRUG

Patients randomised to receive warfarin were initiated on treatment at the baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range.

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

Group Type: EXPERIMENTAL

Warfarin

Intervention Type: DRUG

Patients randomised to receive warfarin were initiated on treatment at the baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range.

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

Group Type: ACTIVE_COMPARATOR

aspirin

Intervention Type: DRUG

100mg aspirin was administrated every day

Interventions

Warfarin

Patients randomised to receive warfarin were initiated on treatment at the baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range.

Intervention Type: DRUG

aspirin

100mg aspirin was administrated every day

Intervention Type: DRUG

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

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 94 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wu Jun

First Affiliated Hospital of Nanjing Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guo Yan, doctor

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

First Affiliated Hospital of Nanjing Medical University, Division of Geriatrics

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 23200268 (View on PubMed)

Other Identifiers

30900602

Identifier Type: -

Identifier Source: org_study_id