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

January 4, 2016 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard intensity warfarin group
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)
Drug: standard intensity warfarin
target international normalised ratio(INR) was 2.1-3.0
Experimental: low intensity warfarin group
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)
Drug: low intensity warfarin
target international normalised ratio(INR) was 1.7-2.2
Active Comparator: dabigatran etexilate group
110mg dabigatran etexilate was administrated twice a day
Drug: dabigatran etexilate
110mg, twice a day, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischaemic stroke
Time Frame: 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.
2 years
major haemorrhage
Time Frame: 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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wu Jun, doctor, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

January 3, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEL102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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