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

Atrial Fibrillation Clinical Trial

— RE-CONOCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285373
• Other study ID #: 1160-0287
• Status: Completed
• Start date: November 29, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1008
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• NOAC
New Oral Anticoagulant

Locations

Country	Name	City	State
Spain	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	H. del Mar	Barcelona
Spain	H. Moisés Broggi	Barcelona
Spain	H. Residencia Sant Camil	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Medical Practice	Barcelona
Spain	Hospital Basurto	Bilbao
Spain	H Aranda Duero	Burgos
Spain	Hospital de Cáceres	Cáceres
Spain	Medical Practice	Castellón
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	H. Quirón Salud H. Sur Alcorcón	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital Gregorio Marañon	Madrid
Spain	Hospital Nuestra Señora del Rosario	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	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 Duque del Infantado	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Medical Practice	Sevilla
Spain	Hospital Santa Santa Bárbara	Soria
Spain	Hospital Universitari de Tarragona Joan XXIII	Tarragona
Spain	Complejo H. Universitario de Canarias	Tenerife
Spain	Hospital Nuestra Señora de la Candelaria	Tenerife
Spain	HM Hospitales Madrid	Torrelodones (Madrid)
Spain	Clínica Santa Elena	Torremolinos (Málaga)
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Number of Patients With Previous Treatment With Vitamin K Antagonists	Number of patient with Previous Treatment with Vitamin K Antagonists.	single visit (Day 1)
Secondary	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.
Secondary	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)