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

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Drug: standard intensity warfarin; Drug: low intensity warfarin; Drug: dabigatran etexilate

• Registration Number: NCT02646267
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-03
• Study First Submitted QC: 2016-01-04
• Last Update Submitted: 2016-01-04
• Study First Posted: 2016-01-05
• Last Update Posted: 2016-01-05
• Study Start: 2016-03
• Primary Completion: 2018-01
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard intensity warfarin group	standard intensity warfarin	standard intensity warfarin group， target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0)
low intensity warfarin group	low intensity warfarin	low intensity warfarin group， target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2)
dabigatran etexilate group	dabigatran etexilate	110mg dabigatran etexilate was administrated twice a day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
minor bleeding	2 years
cardiovascular death	2 years
all-cause mortality	2 years
myocardial infarction	2 years
pulmonary embolism	2 years

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China