NCT03183843

Brief Summary

The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.

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
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2016

Typical duration for phase_4

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

Study Start

First participant enrolled

June 29, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 8, 2017

Last Update Submit

June 8, 2017

Conditions

Mitral Valve Stenosis and InsufficiencyAtrial Fibrillation

Keywords

Atrial FibrillationMitral Valve StenosisMitral Valve InsufficiencyDabigatranBiological ProsthesisMitral Valve ReplacementCox-Maze Procedure

Outcome Measures

Primary Outcomes (1)

  • Thrombosis

    Thrombosis of prosthetic valve, transient ischemic attack, stroke, myocardial infarction, pulmonary and systemic thromboembolic events

    1 year

Secondary Outcomes (1)

  • Major Bleeding

    1 year

Study Arms (2)

Dabigatran

ACTIVE COMPARATOR

Dabigatran etexilate 150 mg by mouth every 12 hours for a year

Drug: Dabigatran Etexilate

Warfarin

ACTIVE COMPARATOR

Warfarin by mouth every 24 hours in a dose providing international normalized ratio (INR) 2.5-3.5 for a year

Drug: Warfarin

Interventions

Dabigatran EtexilateDRUG

Dabigatran Etexilate 150 mg capsules for oral administration twice a day

Also known as: Pradaxa
Dabigatran
WarfarinDRUG

Warfarin 2.5 mg tablets for oral administration once a day

Also known as: Coumadin
Warfarin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mitral valve disease;
  • atrial fibrillation;
  • mitral valve prosthetic replacement with concomitant Cox-Maze Procedure;
  • years of age;
  • signed informed consent form.

You may not qualify if:

  • mechanical valve replacement;
  • repeated mitral valve surgery;
  • coronary artery hemodynamically significant stenoses;
  • ventricular arrhythmias;
  • creatinine clearance \<50 ml/min;
  • HAS-BLED score \>3;
  • previous stroke or transient ischemic attack;
  • liver diseases;
  • neoplasia;
  • pregnancy;
  • simultaneous antiplatelet therapy;
  • allergic reactions on Dabigatran or Warfarin;
  • cognitive disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute for Complex Problems of Cardiovascular Diseases

Kemerovo, 650061, Russia

Location

Related Publications (2)

  • Yadlapati A, Groh C, Malaisrie SC, Gajjar M, Kruse J, Meyers S, Passman R. Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves. Clin Res Cardiol. 2016 Mar;105(3):268-72. doi: 10.1007/s00392-015-0919-z. Epub 2015 Sep 18.

    PMID: 26384981BACKGROUND

  • Sun JC, Davidson MJ, Lamy A, Eikelboom JW. Antithrombotic management of patients with prosthetic heart valves: current evidence and future trends. Lancet. 2009 Aug 15;374(9689):565-76. doi: 10.1016/S0140-6736(09)60780-7.

    PMID: 19683642BACKGROUND

MeSH Terms

Conditions

Mitral Valve StenosisAtrial FibrillationMitral Valve Insufficiency

Interventions

DabigatranWarfarin

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Study Officials

  • Yevgeny V Grigoriev, M.D., Ph.D.

    Research Institute for Complex Problems of Cardiovascular Diseases

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Cardiovascular Disorders Diagnosis

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 12, 2017

Study Start

June 29, 2016

Primary Completion

June 30, 2018

Study Completion

December 1, 2018

Last Updated

June 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)