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

NCT01438580 | Completed Phase 4 DMC

• 1 other identifier: 30900602
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; stroke; warfarin; aspirin

Outcome Measures

Primary Outcomes (2)

• 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. Follow-up study visits were scheduled for once a week in the first month and then every 3 months. The number and results of INR tests, liver and kidney function tests were recorded. In addition, the number of bleeding events was recorded.

  2 years

• 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. Follow-up study visits were scheduled for once a week in the first month and then every 3 months. The number and results of INR tests, liver and kidney function tests were recorded. In addition, the number of ischaemic stroke was recorded.

  2 years

Secondary Outcomes (5)

• minor bleeding

  2.5years

• myocardial infarction

  2.5 years

• deep vein thrombosis

  2.5 years

• pulmonary embolism

  2.5 years

• cardiovascular death

  2.5 years

Study Arms (3)

standard intensity warfarin group

EXPERIMENTAL

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

Drug: Warfarin

low intensity warfarin group

EXPERIMENTAL

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

Drug: Warfarin

aspirin group

ACTIVE COMPARATOR

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

Drug: aspirin

Interventions

Warfarin 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; standard intensity warfarin group

aspirin DRUG

100mg aspirin was administrated every day

aspirin group

Eligibility Criteria

• Age: 75 Years - 94 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Clinical diagnosis of atrial fibrillation
• Echocardiography confirmed a non-valvular heart disease
• Age≥75 years

You may not qualify if:

• Unable to cooperate with doctors
• 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 aspirin
• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University, Division of Geriatrics

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

• 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.

  PMID: 23200268 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Warfarin; Aspirin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Guo Yan, doctor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Affiliated Hospital of Nanjing Medical University

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 22, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

CN (1)