This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain

NCT ID: NCT03993119

Last Updated: 2021-09-29

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-30

Study Completion Date

2020-08-20

Brief Summary

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This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.

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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patients with NVAF

Non-vitamin K antagonist oral anticoagulant

Intervention Type DRUG

Non-vitamin K antagonist oral anticoagulant

Interventions

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Non-vitamin K antagonist oral anticoagulant

Non-vitamin K antagonist oral anticoagulant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients are willing and provide written informed consent prior to participate in this study
* Patients ≥ 75 years-old at the time of the study visit.
* Patients with a diagnosis of non-valvular atrial fibrillation (NVAF).
* Patients who are being treated with NOAC treatment according to the indication approved in the Summary of Product Characteristics (SmPC).
* Patients who have started the NOAC treatment at least 3 months prior to the study visit.

Exclusion Criteria

Patients will be excluded from participating in this study if the following criterion is met:

* Current participation in any clinical trial of a drug or device.
* Patients who have any contraindication for NOAC treatment, according to the SmPC.
Minimum Eligible Age

75 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, (+34) 93 404 58 77

Role: STUDY_CHAIR

[email protected]

Locations

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H. Fundación Alcorcón

Alcorcón, Madrid, , Spain

Site Status

Consulta Privada

Almería, , Spain

Site Status

H. Dr. José Molina Orosa

Arrecife, Las Palmas, , Spain

Site Status

Centro Médico San Juan de Dios

Barakaldo, Bizkaia, , Spain

Site Status

H. Sagrat Cor

Barcelona, , Spain

Site Status

H. Vall d'Hebron

Barcelona, , Spain

Site Status

H. Sant Pau

Barcelona, , Spain

Site Status

H. Vithas Internacional Xanit

Benalmádena, Málaga, , Spain

Site Status

Ambulatorio Txurdinaga

Bilbao, , Spain

Site Status

H. San Juan de Dios de Bormujos

Bormujos, Sevilla, , Spain

Site Status

H. Provincial de Castellón

Castellon, , Spain

Site Status

H. San Pedro Alcántara

Cáceres, , Spain

Site Status

Consulta privada Dr. Ruiz

Córdoba, , Spain

Site Status

H. Arquitecto Marcide

Ferrol, A Coruña, , Spain

Site Status

H. de Jaen

Jaén, , Spain

Site Status

H. U. de León

León, , Spain

Site Status

H. Arnau de Vilanova

Lleida, , Spain

Site Status

H. Lucus Augusti

Lugo, , Spain

Site Status

H. La Princesa

Madrid, , Spain

Site Status

Sanitas La Zarzuela

Madrid, , Spain

Site Status

H. Central de la Defensa Gómez

Madrid, , Spain

Site Status

H. Puerta de Hierro

Majadahonda, Madrid, , Spain

Site Status

H. de Mataró

Mataró, Barcelona, , Spain

Site Status

Consulta Privada

Málaga, , Spain

Site Status

H. de Mendaro

Mendaro, Guipúzcoa, , Spain

Site Status

H. Morales Meseguer

Murcia, , Spain

Site Status

H. Virgen de la Arrixaca

Murcia, , Spain

Site Status

Consulta privada Merelles Otero

Ourense, , Spain

Site Status

Consulta Privada

Ourense, , Spain

Site Status

H. Río Carrión

Palencia, , Spain

Site Status

H. Son Llatzer

Palma de Mallorca, , Spain

Site Status

H. de Navarra

Pamplona, , Spain

Site Status

H. Comarcal de la Vega Baja

San Bartolomé, Alicante, , Spain

Site Status

H. Moises Broggi

Sant Joan Despí, Barcelona, , Spain

Site Status

H. Marqués de Valdecilla

Santander, , Spain

Site Status

H. Álvarez-Buylla

Santullano, Asturias, , Spain

Site Status

H. Virgen de la Macarena

Seville, , Spain

Site Status

H. Virgen del Valle

Toledo, , Spain

Site Status

H. de Torrejón

Torrejón de Ardoz, Madrid, , Spain

Site Status

Consulta Privada

Valencia, , Spain

Site Status

H. General de Valencia

Valencia, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

H. Virgen de la Concha

Zamora, , Spain

Site Status

H. Clínico Lozano Blesa

Zaragoza, , Spain

Site Status

H. Miguel Servet

Zaragoza, , 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

Related Links

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Other Identifiers

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1160-0297

Identifier Type: -

Identifier Source: org_study_id

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