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

NCT03285373 | Completed Results FDA Drug

• 1 other identifier: 1160-0287
• Study Type: observational
• Target: 1,008
• Locations: 1 country
• Sites: 75

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

Outcome Measures

Primary Outcomes (5)

• Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation

  Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.

  Start of the first NOAC treatment

• Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation

  Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.

  Start of the first NOAC treatment

• Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation

  Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 1. Low risk (score 0 in male; score 1 in female) 2. Moderate risk (score 1 in male; score 2 in female) 3. High risk (score ≥2 in male; score ≥3 in female)

  Start of the first NOAC treatment

• Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation

  Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.

  Start of the first NOAC treatment

• Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation

  Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: 1. Low risk (score 0) 2. Moderate risk (score 1-2) 3. High risk (score ≥3)

  Start of the first NOAC treatment

Secondary Outcomes (9)

• Appropriateness of NOACs Prescription

  single visit (Day 1)

• Mean Number of Visits to the Physician Per Year

  1 year (data collected during single visit on day 1)

• Duration of First NOAC, All NOAC and Subsequent NOAC Treatment

  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.

• Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC

  single visit (Day 1)

• Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose

  single visit (Day 1)

Study Arms (1)

patients with NVAF

patients with Non Valvular Atrial Fibrillation

Drug: NOAC

Interventions

NOAC DRUG

New Oral Anticoagulant

patients with NVAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (75)

Clínica Modelo

A Coruña, 15011, Spain

Location

Hospital Universatio de Albacete

Albacete, 2006, Spain

Location

Hospital Quirónsalud Sur

Alcorcón (Madrid), 28922, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Dr. José Molina Orosa

Arrecife, Las Palmas, 35500, Spain

Location

H de Cabueñes

Asturias, 33394, Spain

Location

Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

Clínica Sagrada Familia

Barcelona, 08022, Spain

Location

Medical Practice

Barcelona, 08037, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

H. del Mar

Barcelona, 8003, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

H. Residencia Sant Camil

Barcelona, 8810, Spain

Location

H. Moisés Broggi

Barcelona, 8970, Spain

Location

Hospital Basurto

Bilbao, 48013, Spain

Location

H Aranda Duero

Burgos, 9400, Spain

Location

Medical Practice

Castellon, 12540, Spain

Location

Hospital de Cáceres

Cáceres, 10004, Spain

Location

Medical Practice

Córdoba, 14005, Spain

Location

Medical Practice

Córdoba, 14006, Spain

Location

Centro Médico Puerto

El Puerto de Santa Maria (Cádiz), 11500, Spain

Location

Hospital General de Elche

Elche (Alicante), 03202, Spain

Location

Hospital Vinalopo Salud

Elche (Alicante), 03293, Spain

Location

Hospital García Orcoyen

Estella (Navarra), 31200, Spain

Location

Clínica Del Río Estepona y San Pedro

Estepona (Málaga), 29680, Spain

Location

Complejo Hospitalario Arquitecto Marcide

Ferrol (A Coruña), 15405, Spain

Location

Hospital Galdakao

Galdakao (Vizcaya), 48960, Spain

Location

Medical Practice

Gandía (Valencia), 46702, Spain

Location

Hospital Vithas La Salud

Granada, 18008, Spain

Location

Medical Practice

Granada, 18012, Spain

Location

Medical Practice

Granollers (Barcelona), 08402, Spain

Location

H. U. Guadalajara

Guadalajara, 19002, Spain

Location

Hospital Universitario de Bellvitge

Hospitalet de Ll (Barcelona), 08907, Spain

Location

Hospital Juan Ramon Jiménez

Huelva, 21005, Spain

Location

Medical Practice

Huesca, 22005, Spain

Location

H. Universitario Dr. Negrín

Las Palmas, 35010, Spain

Location

Hospital General San Agustin

Linares (Jaen), 23700, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital Nuestra Señora del Rosario

Madrid, 28006, Spain

Location

Hospital Gregorio Marañon

Madrid, 28009, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

H. Quirón Salud H. Sur Alcorcón

Madrid, 28922, Spain

Location

Hospital Universitario Puerta del Hierro

Majadahonda (Madrid), 28222, Spain

Location

Hospital de Manises

Manises (Valencia), 36940, Spain

Location

Hospital Ochoa

Marbella (Málaga), 29602, Spain

Location

Hospital de Mataró

Mataró (Barcelona), 08304, Spain

Location

Hospital de Mérida

Mérida, 6800, Spain

Location

Hospital Universitario Central de Asturias

Oviedo (Asturias), 33011, Spain

Location

Hospital de Son Llatzer

Palma de Mallorca (Baleares), 07198, Spain

Location

Hospital Quirón Campo de Gibraltar

Palmones (Cádiz), 11379, Spain

Location

Centro de Especialidades Dr. San Martin

Pamplona, 31004, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, 36078, Spain

Location

Hospital Universitari Parc Taulí

Sabadell (Barcelona), 08208, Spain

Location

H. C. U. Salamanca

Salamanca, 37007, Spain

Location

Policlínic Sant Cugat

Sant Cugat Del Valles (Barcelona), 08172, Spain

Location

Hospital Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Complejo H. Universitario de Canarias

Santa Cruz de Tenerife, 38302, Spain

Location

CH Santiago de Compostela

Santiago de Compostela (A Coruña), 15706, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela (A Coruña), 15706, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela (A Coruña), 15706, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Duque del Infantado

Seville, 41012, Spain

Location

Medical Practice

Seville, 41013, Spain

Location

Hospital Santa Santa Bárbara

Soria, 42005, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

Location

HM Hospitales Madrid

Torrelodones (Madrid), 28250, Spain

Location

Clínica Santa Elena

Torremolinos, 29620, Spain

Location

Pius Hospital de Valls

Valls (Tarragona), 43800, Spain

Location

Hospital Universitari de La Plana

Vila-Real (Castellón), 12540, Spain

Location

Hospital Lluis Alcanyis

Xàtiva (Valencia), 46800, Spain

Location

Complejo Asistencial de Zamora

Zamora, 49022, Spain

Location

H. Clínico Universitario

Zaragoza, 50009, Spain

Location

H. Miguel Servet

Zaragoza, 50009, Spain

Location

H. Royo Villanova

Zaragoza, 50015, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Mireia Canals, +34607550925

  mireia.canals@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: November 29, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: February 18, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (75)