Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133545
Recruitment Status : Active, not recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
JOSE LUIS CARLOS NAVARRO, Hospital Italiano de Buenos Aires

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
Auricular Fibrillation Anticoagulant Drugs

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.

Layout table for study information
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 : April 4, 2018
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort
DOAC
Direct oral anticoagulant
OAC
Vitamin K anticoagulant



Primary Outcome Measures :
  1. Anticoagulant Discontinuation Rate [ Time Frame: One year ]
    Anticoagulant Discontinuation Rate


Secondary Outcome Measures :
  1. Discontinuation Predictors [ Time Frame: One year ]
    Discontinuation Predictors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients belonging to a Health Management Organization suffering from atrial fibrillation
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133545


Locations
Layout table for location information
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABB
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Boehringer Ingelheim
Investigators
Layout table for investigator information
Principal Investigator: Jose L Navarrro Estrada, MD Hospital Italiano de Buenos Aires

Layout table for additonal information
Responsible Party: JOSE LUIS CARLOS NAVARRO, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT04133545    
Other Study ID Numbers: Protocol_3525
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants