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

Non-Interventional, Cross-sectional Study to Describe NOACs Management ss in Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: NOAC

• Study Type: Observational
• Enrollment (Actual): 1008

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15011
    • Clínica Modelo
  • Albacete, Spain, 2006
    • Hospital Universatio de Albacete
  • Alcorcón (Madrid), Spain, 28922
    • Hospital Quirónsalud Sur
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Arrecife, Las Palmas, Spain, 35500
    • Hospital Dr. José Molina Orosa
  • Asturias, Spain, 33394
    • H de Cabueñes
  • Badajoz, Spain, 06080
    • Hospital Infanta Cristina
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 8003
    • Hospital del Mar
  • Barcelona, Spain, 08022
    • Clinica Sagrada Familia
  • Barcelona, Spain, 08037
    • Medical Practice
  • Barcelona, Spain, 8003
    • H. del Mar
  • Barcelona, Spain, 8810
    • H. Residencia Sant Camil
  • Barcelona, Spain, 8970
    • H. Moises Broggi
  • Bilbao, Spain, 48013
    • Hospital Basurto
  • Burgos, Spain, 9400
    • H Aranda Duero
  • Castellón, Spain, 12540
    • Medical Practice
  • Cáceres, Spain, 10004
    • Hospital de Cáceres
  • Córdoba, Spain, 14005
    • Medical Practice
  • Córdoba, Spain, 14006
    • Medical Practice
  • El Puerto De Santa Maria (Cádiz), Spain, 11500
    • Centro Médico Puerto
  • Elche (Alicante), Spain, 03202
    • Hospital General de Elche
  • Elche (Alicante), Spain, 03293
    • Hospital Vinalopo Salud
  • Estella (Navarra), Spain, 31200
    • Hospital García Orcoyen
  • Estepona (Málaga), Spain, 29680
    • Clínica Del Río Estepona y San Pedro
  • Ferrol (A Coruña), Spain, 15405
    • Complejo Hospitalario Arquitecto Marcide
  • Galdakao (Vizcaya), Spain, 48960
    • Hospital Galdakao
  • Gandía (Valencia), Spain, 46702
    • Medical Practice
  • Granada, Spain, 18008
    • Hospital Vithas La Salud
  • Granada, Spain, 18012
    • Medical Practice
  • Granollers (Barcelona), Spain, 08402
    • Medical Practice
  • Guadalajara, Spain, 19002
    • H. U. Guadalajara
  • Hospitalet De Ll (Barcelona), Spain, 08907
    • Hospital Universitario de Bellvitge
  • Huelva, Spain, 21005
    • Hospital Juan Ramón Jimenez
  • Huesca, Spain, 22005
    • Medical Practice
  • Las Palmas, Spain, 35010
    • H. Universitario Dr. Negrín
  • Linares (Jaen), Spain, 23700
    • Hospital General San Agustin
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28009
    • Hospital Gregorio Marañon
  • Madrid, Spain, 28006
    • Hospital Nuestra Señora del Rosario
  • Madrid, Spain, 28006
    • Hospital De La Princesa
  • Madrid, Spain, 28040
    • Hospital Fundación Jiménez Díaz
  • Madrid, Spain, 28922
    • H. Quirón Salud H. Sur Alcorcón
  • Majadahonda (Madrid), Spain, 28222
    • Hospital Universitario Puerta del Hierro
  • Manises (Valencia), Spain, 36940
    • Hospital de Manises
  • Marbella (Málaga), Spain, 29602
    • Hospital Ochoa
  • Mataró (Barcelona), Spain, 08304
    • Hospital de Mataró
  • Mérida, Spain, 6800
    • Hospital de Merida
  • Oviedo (Asturias), Spain, 33011
    • Hospital Universitario Central de Asturias
  • Palma De Mallorca (Baleares), Spain, 07198
    • Hospital de Son Llàtzer
  • Palmones (Cádiz), Spain, 11379
    • Hospital Quirón Campo de Gibraltar
  • Pamplona, Spain, 31004
    • Centro de Especialidades Dr. San Martin
  • Pontevedra, Spain, 36078
    • Complejo Hospitalario de Pontevedra
  • Sabadell (Barcelona), Spain, 08208
    • Hospital Universitari Parc Tauli
  • Salamanca, Spain, 37007
    • H. C. U. Salamanca
  • Sant Cugat Del Valles (Barcelona), Spain, 08172
    • Policlínic Sant Cugat
  • Santiago De Compostela (A Coruña), Spain, 15706
    • CH Santiago de Compostela
  • Santiago De Compostela (A Coruña), Spain, 15706
    • Complejo Hospitalario Universitario de Santiago
  • Santiago De Compostela (A Coruña), Spain, 15706
    • Hospital Clinico Universitario de Santiago de Compostela
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41012
    • Hospital Duque del Infantado
  • Sevilla, Spain, 41013
    • Medical Practice
  • Soria, Spain, 42005
    • Hospital Santa Santa Bárbara
  • Tarragona, Spain, 43005
    • Hospital Universitari de Tarragona Joan XXIII
  • Tenerife, Spain, 38010
    • Hospital Nuestra Señora de La Candelaria
  • Tenerife, Spain, 38302
    • Complejo H. Universitario de Canarias
  • Torrelodones (Madrid), Spain, 28250
    • HM Hospitales Madrid
  • Torremolinos (Málaga), Spain, 29620
    • Clínica Santa Elena
  • Valls (Tarragona), Spain, 43800
    • Pius Hospital de Valls
  • Vila-Real (Castellón), Spain, 12540
    • Hospital Universitari de La Plana
  • Xàtiva (Valencia), Spain, 46800
    • Hospital Lluis Alcanyis
  • Zamora, Spain, 49022
    • Complejo Asistencial de Zamora
  • Zaragoza, Spain, 50009
    • H. Miguel Servet
  • Zaragoza, Spain, 50009
    • H. Clinico Universitario
  • Zaragoza, Spain, 50015
    • H. Royo Villanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with NVAF; patients with Non Valvular Atrial Fibrillation	Drug: NOAC; New Oral Anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Low risk (score 0 in male; score 1 in female); Moderate risk (score 1 in male; score 2 in female); 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: Low risk (score 0); Moderate risk (score 1-2); High risk (score ≥3)	Start of the first NOAC treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriateness of NOACs Prescription	Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.	single visit (Day 1)
Mean Number of Visits to the Physician Per Year	Mean number of visits to the physician per year considered for the NOAC Management.	1 year (data collected during single visit on day 1)
Duration of First NOAC, All NOAC and Subsequent NOAC Treatment	Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).	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	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	Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.	single visit (Day 1)
Reason for Treatment Changes	Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.	Start of the first NOAC treatment
Number of Patients With Previous Treatment With Vitamin K Antagonists	Number of patient with Previous Treatment with Vitamin K Antagonists.	single visit (Day 1)
Duration of Previous VKA Treatment	Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC	Through the observational period with an average of 43.8 months, data collected during a single visit.
Patient's Knowledge About His Condition	At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed. Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?	single visit (Day 1)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2017
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (ACTUAL): September 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1160-0287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No