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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02646267
• Other study ID #: SEL102
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: January 3, 2016
• Last updated: January 4, 2016
• Start date: March 2016
• Est. completion date: August 2018

Study information

• Verified date: January 2016
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 210
• Est. completion date: August 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• standard intensity warfarin
target international normalised ratio(INR) was 2.1-3.0
• low intensity warfarin
target international normalised ratio(INR) was 1.7-2.2
• dabigatran etexilate
110mg, twice a day, oral

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No
Primary	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.	2 years	Yes
Secondary	minor bleeding		2 years	Yes
Secondary	myocardial infarction		2 years	No
Secondary	pulmonary embolism		2 years	No
Secondary	cardiovascular death		2 years	No
Secondary	all-cause mortality		2 years	No