Clinical trial NCT03285373: This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain
Official title: Non-Interventional, Cross-sectional Study to Describe NOACs Management ss in Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 1008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 1.000 patients with NVAF currently on NOAC treatment and having initiated their first NOAC starting from November 2016 (Health Authorities positioning report publication) are planned to be included in the study. To minimize selection bias at the patient level, 10 consecutive patients from each site who meet entry criteria will be enrolled.

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.


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

Primary outcomes:
measure: Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
timeFrame: Start of the first NOAC treatment
measure: Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
timeFrame: Start of the first NOAC treatment
measure: Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
timeFrame: Start of the first NOAC treatment
measure: Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation
timeFrame: Start of the first NOAC treatment
measure: Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation
timeFrame: Start of the first NOAC treatment
Secondary outcomes:
measure: Appropriateness of NOACs Prescription
timeFrame: single visit (Day 1)
measure: Mean Number of Visits to the Physician Per Year
timeFrame: 1 year (data collected during single visit on day 1)
measure: Duration of First NOAC, All NOAC and Subsequent NOAC Treatment
timeFrame: Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.
measure: Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC
timeFrame: single visit (Day 1)
measure: Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose
timeFrame: single visit (Day 1)
measure: Reason for Treatment Changes
timeFrame: Start of the first NOAC treatment
measure: Number of Patients With Previous Treatment With Vitamin K Antagonists
timeFrame: single visit (Day 1)
measure: Duration of Previous VKA Treatment
timeFrame: Through the observational period with an average of 43.8 months, data collected during a single visit.
measure: Patient's Knowledge About His Condition
timeFrame: single visit (Day 1)
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Clínica Modelo
city: Albacete
country: Spain
facility: Hospital Universatio de Albacete
city: Alcorcón (Madrid)
country: Spain
facility: Hospital Quirónsalud Sur
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Arrecife, Las Palmas
country: Spain
facility: Hospital Dr. José Molina Orosa
city: Asturias
country: Spain
facility: H de Cabueñes
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barcelona
country: Spain
facility: Clínica Sagrada Familia
city: Barcelona
country: Spain
facility: Medical Practice
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: H. del Mar
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: H. Residencia Sant Camil
city: Barcelona
country: Spain
facility: H. Moisés Broggi
city: Bilbao
country: Spain
facility: Hospital Basurto
city: Burgos
country: Spain
facility: H Aranda Duero
city: Castellón
country: Spain
facility: Medical Practice
city: Cáceres
country: Spain
facility: Hospital de Cáceres
city: Córdoba
country: Spain
facility: Medical Practice
city: Córdoba
country: Spain
facility: Medical Practice
city: El Puerto De Santa Maria (Cádiz)
country: Spain
facility: Centro Médico Puerto
city: Elche (Alicante)
country: Spain
facility: Hospital General de Elche
city: Elche (Alicante)
country: Spain
facility: Hospital Vinalopo Salud
city: Estella (Navarra)
country: Spain
facility: Hospital García Orcoyen
city: Estepona (Málaga)
country: Spain
facility: Clínica Del Río Estepona y San Pedro
city: Ferrol (A Coruña)
country: Spain
facility: Complejo Hospitalario Arquitecto Marcide
city: Galdakao (Vizcaya)
country: Spain
facility: Hospital Galdakao
city: Gandía (Valencia)
country: Spain
facility: Medical Practice
city: Granada
country: Spain
facility: Hospital Vithas La Salud
city: Granada
country: Spain
facility: Medical Practice
city: Granollers (Barcelona)
country: Spain
facility: Medical Practice
city: Guadalajara
country: Spain
facility: H. U. Guadalajara
city: Hospitalet De Ll (Barcelona)
country: Spain
facility: Hospital Universitario de Bellvitge
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jiménez
city: Huesca
country: Spain
facility: Medical Practice
city: Las Palmas
country: Spain
facility: H. Universitario Dr. Negrín
city: Linares (Jaen)
country: Spain
facility: Hospital General San Agustin
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Nuestra Señora del Rosario
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: H. Quirón Salud H. Sur Alcorcón
city: Majadahonda (Madrid)
country: Spain
facility: Hospital Universitario Puerta del Hierro
city: Manises (Valencia)
country: Spain
facility: Hospital de Manises
city: Marbella (Málaga)
country: Spain
facility: Hospital Ochoa
city: Mataró (Barcelona)
country: Spain
facility: Hospital de Mataró
city: Mérida
country: Spain
facility: Hospital de Mérida
city: Oviedo (Asturias)
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma De Mallorca (Baleares)
country: Spain
facility: Hospital de Son Llatzer
city: Palmones (Cádiz)
country: Spain
facility: Hospital Quirón Campo de Gibraltar
city: Pamplona
country: Spain
facility: Centro de Especialidades Dr. San Martin
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Sabadell (Barcelona)
country: Spain
facility: Hospital Universitari Parc Taulí
city: Salamanca
country: Spain
facility: H. C. U. Salamanca
city: Sant Cugat Del Valles (Barcelona)
country: Spain
facility: Policlínic Sant Cugat
city: Santiago De Compostela (A Coruña)
country: Spain
facility: CH Santiago de Compostela
city: Santiago De Compostela (A Coruña)
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Santiago De Compostela (A Coruña)
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Duque del Infantado
city: Sevilla
country: Spain
facility: Medical Practice
city: Soria
country: Spain
facility: Hospital Santa Santa Bárbara
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
city: Tenerife
country: Spain
facility: Hospital Nuestra Señora de la Candelaria
city: Tenerife
country: Spain
facility: Complejo H. Universitario de Canarias
city: Torrelodones (Madrid)
country: Spain
facility: HM Hospitales Madrid
city: Torremolinos (Málaga)
country: Spain
facility: Clínica Santa Elena
city: Valls (Tarragona)
country: Spain
facility: Pius Hospital de Valls
city: Vila-Real (Castellón)
country: Spain
facility: Hospital Universitari de La Plana
city: Xàtiva (Valencia)
country: Spain
facility: Hospital Lluis Alcanyis
city: Zamora
country: Spain
facility: Complejo Asistencial de Zamora
city: Zaragoza
country: Spain
facility: H. Clínico Universitario
city: Zaragoza
country: Spain
facility: H. Miguel Servet
city: Zaragoza
country: Spain
facility: H. Royo Villanova
Study officials:
affiliation: mireia.canals@boehringer-ingelheim.com
name: Mireia Canals, +34607550925
role: STUDY_CHAIR
References: