NCT01546883

Brief Summary

This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an anti-coagulant for a period of one year to see if there are any significant changes in the degree of left atrial structural remodeling in these patients. The investigators hypothesize that there will be a significant decrease in the degree of left atrial structural remodeling (fibrosis) in AF patients treated with dabigatran.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

February 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 12, 2015

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

February 15, 2012

Results QC Date

August 11, 2015

Last Update Submit

September 10, 2015

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationMRI

Outcome Measures

Primary Outcomes (1)

  • Percentage of Fibrosis

    We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.

    MRI at baseline and MRI at 12 months post-enrollment

Study Arms (1)

Dabigatran

EXPERIMENTAL

Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant

Drug: Dabigatran etexilate (Pradaxa)

Interventions

Dabigatran etexilate (Pradaxa)DRUG

150mg bid or 75mg bid for a period of one year

Also known as: Pradaxa
Dabigatran

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with all types of non-valvular AF (includes paroxysmal, persistent and permanent AF)
  • Candidate for anticoagulation therapy
  • No contra-indication for LGE-MRI
  • Patients age 18 and older
  • Patients who are able to provide informed consent to participate in the study

You may not qualify if:

  • Patients who have already undergone an atrial fibrillation ablation procedure.
  • Patients with active contra-indications to any anticoagulant agent.
  • Other major bleeding disorders or risk factors that would place the patient at risk of bleeding.
  • Recent surgery (within 30 days).
  • Renal insufficiency, severe kidney disorders/diseases, GFR \< 30mg/dL (Gadolinium contraindication).
  • Advanced liver disease.
  • Any health related Gadolinium/MRI contraindications: Pacemaker devices, etc.
  • Pregnant, planning to be become pregnant or nursing women
  • Individuals who are unable to provide informed consent
  • Contraindicated for Pradaxa® .
  • Patients the Investigators feel are inappropriate for the study
  • Patients who cannot give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

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

Results Point of Contact

Title
Clinical Research Manager
Organization
University of Utah
christina.pacchia@hsc.utah.edu
8015873889

Study Officials

  • Nassir F Marrouche, MD, FHRS

    University of Utah, CARMA center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2012

First Posted

March 7, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 12, 2015

Results First Posted

October 12, 2015

Record last verified: 2015-09

Locations

US(1)