This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain

NCT ID: NCT03285373

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1008 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2019-01-31

Brief Summary

The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

patients with NVAF

patients with Non Valvular Atrial Fibrillation

NOAC

Intervention Type: DRUG

New Oral Anticoagulant

Interventions

NOAC

New Oral Anticoagulant

Intervention Type: DRUG

Eligibility Criteria

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 (NVAF)
• The patient is on treatment with NOAC according to its approved local SmPC and has initiated his first NOAC starting from November 2016

Exclusion Criteria

-if the current participating patient participate in any clinical trial of a drug or device will be excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mireia Canals, +34607550925

Role: STUDY_CHAIR

mireia.canals@boehringer-ingelheim.com

Locations

Clínica Modelo

A Coruña, , Spain

Hospital Universatio de Albacete

Albacete, , Spain

Hospital Quirónsalud Sur

Alcorcón (Madrid), , Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Dr. José Molina Orosa

Arrecife, Las Palmas, , Spain

H de Cabueñes

Asturias, , Spain

Hospital Infanta Cristina

Badajoz, , Spain

Clínica Sagrada Familia

Barcelona, , Spain

Medical Practice

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

H. del Mar

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

H. Residencia Sant Camil

Barcelona, , Spain

H. Moisés Broggi

Barcelona, , Spain

Hospital Basurto

Bilbao, , Spain

H Aranda Duero

Burgos, , Spain

Medical Practice

Castellon, , Spain

Hospital de Cáceres

Cáceres, , Spain

Medical Practice

Córdoba, , Spain

Medical Practice

Córdoba, , Spain

Centro Médico Puerto

El Puerto de Santa Maria (Cádiz), , Spain

Hospital General de Elche

Elche (Alicante), , Spain

Hospital Vinalopo Salud

Elche (Alicante), , Spain

Hospital García Orcoyen

Estella (Navarra), , Spain

Clínica Del Río Estepona y San Pedro

Estepona (Málaga), , Spain

Complejo Hospitalario Arquitecto Marcide

Ferrol (A Coruña), , Spain

Hospital Galdakao

Galdakao (Vizcaya), , Spain

Medical Practice

Gandía (Valencia), , Spain

Hospital Vithas La Salud

Granada, , Spain

Medical Practice

Granada, , Spain

Medical Practice

Granollers (Barcelona), , Spain

H. U. Guadalajara

Guadalajara, , Spain

Hospital Universitario de Bellvitge

Hospitalet de Ll (Barcelona), , Spain

Hospital Juan Ramon Jiménez

Huelva, , Spain

Medical Practice

Huesca, , Spain

H. Universitario Dr. Negrín

Las Palmas, , Spain

Hospital General San Agustin

Linares (Jaen), , Spain

Hospital Universitario Lucus Augusti

Lugo, , Spain

Hospital de la Princesa

Madrid, , Spain

Hospital Nuestra Señora del Rosario

Madrid, , Spain

Hospital Gregorio Marañon

Madrid, , Spain

Hospital Fundación Jiménez Díaz

Madrid, , Spain

H. Quirón Salud H. Sur Alcorcón

Madrid, , Spain

Hospital Universitario Puerta del Hierro

Majadahonda (Madrid), , Spain

Hospital de Manises

Manises (Valencia), , Spain

Hospital Ochoa

Marbella (Málaga), , Spain

Hospital de Mataró

Mataró (Barcelona), , Spain

Hospital de Mérida

Mérida, , Spain

Hospital Universitario Central de Asturias

Oviedo (Asturias), , Spain

Hospital de Son Llatzer

Palma de Mallorca (Baleares), , Spain

Hospital Quirón Campo de Gibraltar

Palmones (Cádiz), , Spain

Centro de Especialidades Dr. San Martin

Pamplona, , Spain

Complejo Hospitalario de Pontevedra

Pontevedra, , Spain

Hospital Universitari Parc Taulí

Sabadell (Barcelona), , Spain

H. C. U. Salamanca

Salamanca, , Spain

Policlínic Sant Cugat

Sant Cugat Del Valles (Barcelona), , Spain

Hospital Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, , Spain

Complejo H. Universitario de Canarias

Santa Cruz de Tenerife, , Spain

CH Santiago de Compostela

Santiago de Compostela (A Coruña), , Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela (A Coruña), , Spain

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela (A Coruña), , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Duque del Infantado

Seville, , Spain

Medical Practice

Seville, , Spain

Hospital Santa Santa Bárbara

Soria, , Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, , Spain

HM Hospitales Madrid

Torrelodones (Madrid), , Spain

Clínica Santa Elena

Torremolinos, , Spain

Pius Hospital de Valls

Valls (Tarragona), , Spain

Hospital Universitari de La Plana

Vila-Real (Castellón), , Spain

Hospital Lluis Alcanyis

Xàtiva (Valencia), , Spain

Complejo Asistencial de Zamora

Zamora, , Spain

H. Clínico Universitario

Zaragoza, , Spain

H. Miguel Servet

Zaragoza, , Spain

H. Royo Villanova

Zaragoza, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1160-0287

Identifier Type: -

Identifier Source: org_study_id