Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation

Discontinuation for Oral Anticoagulants During the First Year of Use in Patients With Atrial Fibrillation Covered by a Medical Insurance

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

Study Overview

• Status: Unknown
• Conditions: Anticoagulant Drugs; Auricular Fibrillation

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 Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients belonging to a Health Management Organization suffering from atrial fibrillation

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
DOAC; Direct oral anticoagulant
OAC; Vitamin K anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticoagulant Discontinuation Rate	Anticoagulant Discontinuation Rate	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discontinuation Predictors	Discontinuation Predictors	One year

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Jose L Navarrro Estrada, MD, Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Protocol_3525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No