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Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Unknown status
CT.gov ID
NCT04133545
Collaborator
Boehringer Ingelheim (Industry)
360
Enrollment
1
Location
28.9
Anticipated Duration (Months)
12.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year of use after their initiation during hospitalization in patients covered by our health insurance plan.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    360 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Discontinuation for Oral Anticoagulants During the First Year of Use in Patients With Atrial Fibrillation Covered by a Medical Insurance
    Actual Study Start Date :
    Apr 4, 2018
    Actual Primary Completion Date :
    Sep 30, 2019
    Anticipated Study Completion Date :
    Sep 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    DOAC

    Direct oral anticoagulant
    OAC

    Vitamin K anticoagulant

    Outcome Measures

    Primary Outcome Measures

    1. Anticoagulant Discontinuation Rate [One year]

      Anticoagulant Discontinuation Rate

    Secondary Outcome Measures

    1. Discontinuation Predictors [One year]

      Discontinuation Predictors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient older than 18 years of age covered by our Health Care Insurance Plan.

    2. Indication for oral anticoagulation with an expected duration of use of no less than 1 year.

    Exclusion Criteria:

    1. Refusal to take part.

    2. Use of oral anticoagulants within 6 months prior to admission.

    3. Presence of mechanical prosthetic valve.

    4. Chronic renal failure with creatinine clearance <30 mL/min (estimated using the MDRD formula).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Italiano de Buenos Aires Buenos Aires Argentina C1199ABB

    Sponsors and Collaborators

    • Hospital Italiano de Buenos Aires
    • Boehringer Ingelheim

    Investigators

    • Principal Investigator: Jose L Navarrro Estrada, MD, Hospital Italiano de Buenos Aires

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JOSE LUIS CARLOS NAVARRO, MD, Hospital Italiano de Buenos Aires
    ClinicalTrials.gov Identifier:
    NCT04133545
    Other Study ID Numbers:
    • Protocol_3525
    First Posted:
    Oct 21, 2019
    Last Update Posted:
    Oct 21, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Oct 21, 2019