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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02646267

Enrollment

210

Registered

2016-01-05

Start date

2016-03-31

Completion date

2018-08-31

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Dabigatran, Warfarin, Anticoagulation, Elderly

Brief summary

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.

Interventions

DRUGstandard intensity warfarin

target international normalised ratio(INR) was 2.1-3.0

DRUGlow intensity warfarin

target international normalised ratio(INR) was 1.7-2.2

DRUGdabigatran etexilate

110mg, twice a day, oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ischaemic stroke	2 years	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.
major haemorrhage	2 years	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.

Secondary

Measure	Time frame
pulmonary embolism	2 years
minor bleeding	2 years
all-cause mortality	2 years
cardiovascular death	2 years
myocardial infarction	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026