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

Nanjing Medical University

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: low intensity warfarin; Drug: standard intensity warfarin; Drug: dabigatran etexilate

Study type: Interventional

Funder types: Other

Identifiers

NCT02646267

SEL102

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

standard intensity warfarin group

Experimental group

Description:

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)

Treatment:

Drug: standard intensity warfarin

low intensity warfarin group

Experimental group

Description:

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)

Treatment:

Drug: low intensity warfarin

dabigatran etexilate group

Active Comparator group

Description:

110mg dabigatran etexilate was administrated twice a day

Treatment:

Drug: dabigatran etexilate