Clinical trial NCT03993119: This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain
Official title: Non-Interventional, Cross-sectional Study to Describe NOACs Management in Elderly 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: 2019-06-20
Enrollment: 500
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 500 elderly patients with NVAF currently on NOAC treatment are planned to be included in the study. To minimize selection bias at the patient level, consecutive patients from each site who meet entry criteria will be enrolled. It is planned to have a 9-month recruitment period from first site initiated, or until the sample size is achieved.

Brief summary: This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.


Eligibility criteria: Inclusion Criteria:

* Patients are willing and provide written informed consent prior to participate in this study
* Patients ≥ 75 years-old at the time of the study visit.
* Patients with a diagnosis of non-valvular atrial fibrillation (NVAF).
* Patients who are being treated with NOAC treatment according to the indication approved in the Summary of Product Characteristics (SmPC).
* Patients who have started the NOAC treatment at least 3 months prior to the study visit.

Exclusion Criteria:

Patients will be excluded from participating in this study if the following criterion is met:

* Current participation in any clinical trial of a drug or device.
* Patients who have any contraindication for NOAC treatment, according to the SmPC.

Primary outcomes:
measure: Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
timeFrame: At the single study visit (Day 1).
measure: Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex
timeFrame: At the single study visit (Day 1).
measure: Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
timeFrame: At the single study visit (Day 1).
measure: Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical)
timeFrame: At the single study visit (Day 1).
measure: Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
timeFrame: At the single study visit (Day 1).
measure: Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure
timeFrame: At the single study visit (Day 1).
measure: Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
timeFrame: At the single study visit (Day 1).
measure: Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease
timeFrame: At the single study visit (Day 1).
measure: Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
timeFrame: At the single study visit (Day 1).
measure: Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes
timeFrame: At the single study visit (Day 1).
measure: Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
timeFrame: At the single study visit (Day 1).
measure: Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease
timeFrame: At the single study visit (Day 1).
Secondary outcomes:
measure: Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (day 1).
measure: Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (day 1).
measure: Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type
timeFrame: At the single study visit (day 1).
measure: Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
timeFrame: At the single study visit (Day 1).
measure: Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
timeFrame: At the single study visit (Day 1).
measure: Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
timeFrame: At the single study visit (Day 1).
measure: Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
timeFrame: At the single study visit (Day 1).
measure: Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
timeFrame: At the single study visit (Day 1).
measure: Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type
timeFrame: At the single study visit (Day 1).
Other outcomes:
Locations:
city: Alcorcón, Madrid
country: Spain
facility: H. Fundación Alcorcón
city: Almería
country: Spain
facility: Consulta Privada
city: Arrecife, Las Palmas
country: Spain
facility: H. Dr. José Molina Orosa
city: Barakaldo, Bizkaia
country: Spain
facility: Centro Médico San Juan de Dios
city: Barcelona
country: Spain
facility: H. Sagrat Cor
city: Barcelona
country: Spain
facility: H. Vall d'Hebron
city: Barcelona
country: Spain
facility: H. Sant Pau
city: Benalmádena, Málaga
country: Spain
facility: H. Vithas Internacional Xanit
city: Bilbao
country: Spain
facility: Ambulatorio Txurdinaga
city: Bormujos, Sevilla
country: Spain
facility: H. San Juan de Dios de Bormujos
city: Castellón
country: Spain
facility: H. Provincial de Castellón
city: Cáceres
country: Spain
facility: H. San Pedro Alcántara
city: Córdoba
country: Spain
facility: Consulta privada Dr. Ruiz
city: Ferrol, A Coruña
country: Spain
facility: H. Arquitecto Marcide
city: Jaen
country: Spain
facility: H. de Jaen
city: León
country: Spain
facility: H. U. de León
city: Lleida
country: Spain
facility: H. Arnau de Vilanova
city: Lugo
country: Spain
facility: H. Lucus Augusti
city: Madrid
country: Spain
facility: H. La Princesa
city: Madrid
country: Spain
facility: Sanitas La Zarzuela
city: Madrid
country: Spain
facility: H. Central de la Defensa Gómez
city: Majadahonda, Madrid
country: Spain
facility: H. Puerta de Hierro
city: Mataró, Barcelona
country: Spain
facility: H. de Mataró
city: Mendaro, Guipúzcoa
country: Spain
facility: H. de Mendaro
city: Murcia
country: Spain
facility: H. Morales Meseguer
city: Murcia
country: Spain
facility: H. Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Consulta Privada
city: Ourense
country: Spain
facility: Consulta privada Merelles Otero
city: Ourense
country: Spain
facility: Consulta Privada
city: Palencia
country: Spain
facility: H. Río Carrión
city: Palma de Mallorca
country: Spain
facility: H. Son Llatzer
city: Pamplona
country: Spain
facility: H. de Navarra
city: San Bartolomé, Alicante
country: Spain
facility: H. Comarcal de la Vega Baja
city: Sant Joan Despí, Barcelona
country: Spain
facility: H. Moises Broggi
city: Santander
country: Spain
facility: H. Marqués de Valdecilla
city: Santullano, Asturias
country: Spain
facility: H. Álvarez-Buylla
city: Sevilla
country: Spain
facility: H. Virgen de la Macarena
city: Toledo
country: Spain
facility: H. Virgen del Valle
city: Torrejón De Ardoz, Madrid
country: Spain
facility: H. de Torrejón
city: Valencia
country: Spain
facility: Consulta Privada
city: Valencia
country: Spain
facility: H. General de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Zamora
country: Spain
facility: H. Virgen de la Concha
city: Zaragoza
country: Spain
facility: H. Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: H. Miguel Servet
Study officials:
affiliation: mireia.canals@boehringer-ingelheim.com
name: Mireia canals, (+34) 93 404 58 77
role: STUDY_CHAIR
References: