NCT04133545

Brief Summary

The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year

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
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

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

April 4, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

October 17, 2019

Last Update Submit

October 17, 2019

Conditions

Auricular FibrillationAnticoagulant Drugs

Outcome Measures

Primary Outcomes (1)

  • Anticoagulant Discontinuation Rate

    Anticoagulant Discontinuation Rate

    One year

Secondary Outcomes (1)

  • Discontinuation Predictors

    One year

Study Arms (2)

DOAC

Direct oral anticoagulant

OAC

Vitamin K anticoagulant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients belonging to a Health Management Organization suffering from atrial fibrillation

You may qualify if:

  • Patient older than 18 years of age covered by our Health Care Insurance Plan.
  • Indication for oral anticoagulation with an expected duration of use of no less than 1 year.

You may not qualify if:

  • Refusal to take part.
  • Use of oral anticoagulants within 6 months prior to admission.
  • Presence of mechanical prosthetic valve.
  • Chronic renal failure with creatinine clearance \<30 mL/min (estimated using the MDRD formula).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB, Argentina

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose L Navarrro Estrada, MD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

April 4, 2018

Primary Completion

September 30, 2019

Study Completion

September 1, 2020

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)