Discontinuation for Oral Anticoagulants in Patients With... | NCT04133545

Studies
Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation

NCT04133545

Sponsor

Hospital Italiano de Buenos Aires

Status

Unknown status

Last Update Posted

Oct 21, 2019Actual

Enrollment

360Actual

Phase

Not provided

Conditions

Auricular Fibrillation
Anticoagulant Drugs

Interventions

Not provided

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2018Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 2020Estimated

First Submitted Date

Oct 17, 2019

First Submission Date that Met QC Criteria

Oct 17, 2019

First Posted Date

Oct 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2019

Last Update Posted Date

Oct 21, 2019Actual

Name	Class
Boehringer Ingelheim	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DOAC		Direct oral anticoagulant
OAC		Vitamin K anticoagulant

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Discontinuation Predictors	Discontinuation Predictors	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients belonging to a Health Management Organization suffering from atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose L Navarrro Estrada, MD	Hospital Italiano de Buenos Aires	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Italiano de Buenos Aires		Buenos Aires		C1199ABB	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided