Health-related Quality of Life in Patients on Anticoagulants

NCT ID: NCT03134911

Last Updated: 2019-04-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

535 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-24

Study Completion Date

2018-01-31

Brief Summary

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The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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anticoagulation controlled patients

Treated with DOAC or VKA

DOAC or VKA

Intervention Type DRUG

6 months - 2 years

anticoagulation non controlled patients

Treated with VKA

VKA

Intervention Type DRUG

6 months - 2 years

Interventions

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DOAC or VKA

6 months - 2 years

Intervention Type DRUG

VKA

6 months - 2 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient is willing and provides written informed consent to participate in this study.
* The patient is at least 18 years of age
* The patient has a diagnosis of non-valvular atrial fibrillation
* The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.
* If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it.

Exclusion Criteria

* Current participation in any clinical trial of a drug or device
* Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mireia Canals, +34607550925

Role: STUDY_CHAIR

[email protected]

Locations

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Hospital Universitario Príncipe de Asturias

Alcalá de Henares (Madrid), , Spain

Site Status

HospitalUniversitario Príncipe de Asturias

Alcalá de Henares (Madrid), , Spain

Site Status

Hospita Universitario Fundación Alcorcón

Alcorcón (Madrid), , Spain

Site Status

Hospital Público Virgen de los Lirios

Alcoy (Alicante), , Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital Universitario San Juan de Alicante

Alicante, , Spain

Site Status

Complejo Hospitalario Torrecárdenas

Almería, , Spain

Site Status

Hospital Universitario Monteprincipe

Boadilla Del Monte (Madrid), , Spain

Site Status

Hospital San Juan de Dios

Bormujos (Sevilla), , Spain

Site Status

Hospital General Universitario de Castellón

Castellón de La Plana (Castellón), , Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Hospital General Universitario de Elche

Elche (Alicante), , Spain

Site Status

Hospital Universitario de Fuenlabrada

Fuenlabrada (Madrid), , Spain

Site Status

Hospital Comarcal Francesc de Borja

Gandía (València), , Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital De Llíria (depende del Arnau de Vilanova)

Llíria (Valencia), , Spain

Site Status

Hospital de La Princesa

Madrid, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hopital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Universitario Doce de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro

Majadahonda (Madrid), , Spain

Site Status

Hospital Costa del Sol

Marbella (Málaga), , Spain

Site Status

Complejo Hospitalario de Especialidades Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Regional de Málaga (Carlos Haya)

Málaga, , Spain

Site Status

Hospital Universitario Rey Juan Carlos

Móstoles (Madrid), , Spain

Site Status

Hospital Universitario de Móstoles

Móstoles (Madrid), , Spain

Site Status

Hospital Vega Baja

Orihuela (Alicante), , Spain

Site Status

Hospital Virgen del Camino

Pamplona (Navarra), , Spain

Site Status

Hospital General de Requena

Requena (Valencia), , Spain

Site Status

Hospital de Sagunto

Sagunto (Valencia), , Spain

Site Status

Hospital Universitario Infanta Sofia

San Sebastián de Los Reyes (Madrid), , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Universitario de Torrevieja

Torrrevieja (Alicante), , Spain

Site Status

Hospital Clínico Universitariio de Valencia

Valencia, , Spain

Site Status

Consorcio Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitario de La Plana

Villarreal (Castellón), , Spain

Site Status

Hospital Lluis Alcanyis

Xàtiva (Valencia), , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1160-0280

Identifier Type: -

Identifier Source: org_study_id

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