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

The First Affiliated Hospital with Nanjing Medical University210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Atrial Fibrillation

Interventions

standard intensity warfarinDRUG

target international normalised ratio(INR) was 2.1-3.0

low intensity warfarinDRUG

target international normalised ratio(INR) was 1.7-2.2

dabigatran etexilateDRUG

110mg, twice a day, oral

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical diagnosis of atrial fibrillation 2. Echocardiography confirmed a non-valvular heart disease 3. Age≥60 years Exclusion Criteria: 1. Unable to cooperate with doctors 2. CHA2DS2-VASc\<2 3. Life expectancy of less than 1 year 4. Rheumatic heart disease or dilated cardiomyopathy 5. History of artificial valve replacement surgery 6. Infectious endocarditis 7. Stroke or transient ischemic attack(TIA) within the last 6 months 8. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding 9. Previous intolerance/allergy to warfarin or dabigatran etexilate 10. Blood pressure greater than 180/110 mmHg 11. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times 12. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min 13. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 years

Secondary Outcomes

minor bleeding

Time frame: 2 years

myocardial infarction

Time frame: 2 years

pulmonary embolism

Time frame: 2 years

cardiovascular death

Time frame: 2 years

all-cause mortality

Time frame: 2 years

Data from ClinicalTrials.gov

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