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Local Adaptation of Cost Effectiveness Model for Apixaban Atrial Fibrillation Indication - Venezuela

NCT ID: NCT02756481

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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To characterize treatment patterns and healthcare resource utilization among adults diagnosed with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela.

Detailed Description

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Conditions

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Non-Valvular Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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NVAF Treatment patterns

Treatment patterns will be collected during the follow-up period. Data will be directly extracted from medical charts of the arrhythmia unit.

Anticoagulation use will be reported as drug class: Vitamin K antagonist, antiplatelet, nonsteroidal anti-inflammatory drugs. The following data on anticoagulation use will be collected:

* Type of treatment, start \& stop dates, dosage, administration schedule, method of administration, reason for discontinuation if applicable
* Type of therapy utilized (monotherapy/combination therapy)
* Total number of therapy changes or switches through the course of treatment

* Monitoring visit (visits per month) for International normalized ratio (INR) control by Time in Therapeutic Range(cTTR)
* Routine care (visits per month) by anticoagulation regimen

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with diagnosis of AF (incident and prevalent cases)
* Patient with at least 18 years
* Patients enrolment before and during the study period
* Patients treated in Venezuela

Exclusion Criteria

* Women who were pregnant at any moment during the study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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CV185-333

Identifier Type: -

Identifier Source: org_study_id