NCT02646267

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

January 3, 2016

Last Update Submit

January 4, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationDabigatranWarfarinAnticoagulationElderly

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • minor bleeding

    2 years

  • myocardial infarction

    2 years

  • pulmonary embolism

    2 years

  • cardiovascular death

    2 years

  • all-cause mortality

    2 years

Study Arms (3)

standard intensity warfarin group

EXPERIMENTAL

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

low intensity warfarin group

EXPERIMENTAL

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

dabigatran etexilate group

ACTIVE COMPARATOR

110mg dabigatran etexilate was administrated twice a day

Drug: dabigatran etexilate

Interventions

standard intensity warfarinDRUG

target international normalised ratio(INR) was 2.1-3.0

standard intensity warfarin group
low intensity warfarinDRUG

target international normalised ratio(INR) was 1.7-2.2

low intensity warfarin group
dabigatran etexilateDRUG

110mg, twice a day, oral

dabigatran etexilate group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of atrial fibrillation
  • Echocardiography confirmed a non-valvular heart disease
  • Age≥60 years

You may not qualify if:

  • Unable to cooperate with doctors
  • CHA2DS2-VASc\<2
  • Life expectancy of less than 1 year
  • Rheumatic heart disease or dilated cardiomyopathy
  • History of artificial valve replacement surgery
  • Infectious endocarditis
  • Stroke or transient ischemic attack(TIA) within the last 6 months
  • Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding
  • Previous intolerance/allergy to warfarin or dabigatran etexilate
  • Blood pressure greater than 180/110 mmHg
  • Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times
  • Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min
  • Patient was receiving antiplatelet or anticoagulant therapy due to other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related 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. No abstract available.

    PMID: 23200268BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Wu Jun, doctor

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 5, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2018

Study Completion

August 1, 2018

Last Updated

January 5, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)