This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Non-vitamin K antagonist oral anticoagulant

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Spain
  • Alcorcón, Madrid, Spain, 28922
    • H. Fundación Alcorcón
  • Almería, Spain, 4630
    • Consulta Privada
  • Arrecife, Las Palmas, Spain, 35500
    • H. Dr. Jose Molina Orosa
  • Barakaldo, Bizkaia, Spain, 48901
    • Centro Médico San Juan de Dios
  • Barcelona, Spain, 8035
    • H. Vall d'Hebron
  • Barcelona, Spain, 8029
    • H. Sagrat Cor
  • Barcelona, Spain, 8041
    • H. Sant Pau
  • Benalmádena, Málaga, Spain, 29631
    • H. Vithas Internacional Xanit
  • Bilbao, Spain, 48004
    • Ambulatorio Txurdinaga
  • Bormujos, Sevilla, Spain, 41930
    • H. San Juan de Dios de Bormujos
  • Castellón, Spain, 12002
    • H. Provincial de Castellón
  • Cáceres, Spain, 10003
    • H. San Pedro Alcántara
  • Córdoba, Spain, 14006
    • Consulta privada Dr. Ruiz
  • Ferrol, A Coruña, Spain, 15405
    • H. Arquitecto Marcide
  • Jaen, Spain, 23007
    • H. de Jaen
  • León, Spain, 24008
    • H. U. de León
  • Lleida, Spain, 25198
    • H. Arnau de Vilanova
  • Lugo, Spain, 27003
    • H. Lucus Augusti
  • Madrid, Spain, 28006
    • H. La Princesa
  • Madrid, Spain, 28023
    • Sanitas La Zarzuela
  • Madrid, Spain, 28047
    • H. Central de la Defensa Gómez
  • Majadahonda, Madrid, Spain, 28222
    • H. Puerta de Hierro
  • Mataró, Barcelona, Spain, 8304
    • H. de Mataro
  • Mendaro, Guipúzcoa, Spain, 20850
    • H. de Mendaro
  • Murcia, Spain, 30008
    • H. Morales Meseguer
  • Murcia, Spain, 30120
    • H. Virgen de la Arrixaca
  • Málaga, Spain, 29002
    • Consulta Privada
  • Ourense, Spain, 32003
    • Consulta privada Merelles Otero
  • Ourense, Spain, 32003
    • Consulta Privada
  • Palencia, Spain, 34005
    • H. Río Carrión
  • Palma de Mallorca, Spain, 7198
    • H. Son Llàtzer
  • Pamplona, Spain, 31008
    • H. de Navarra
  • San Bartolomé, Alicante, Spain, 3314
    • H. Comarcal de la Vega Baja
  • Sant Joan Despí, Barcelona, Spain, 8970
    • H. Moises Broggi
  • Santander, Spain, 39008
    • H. Marques De Valdecilla
  • Santullano, Asturias, Spain, 33619
    • H. Álvarez-Buylla
  • Sevilla, Spain, 41009
    • H. Virgen de la Macarena
  • Toledo, Spain, 45071
    • H. Virgen del Valle
  • Torrejón De Ardoz, Madrid, Spain, 28850
    • H. de Torrejón
  • Valencia, Spain, 46026
    • Hospital La Fe
  • Valencia, Spain, 46005
    • Consulta Privada
  • Valencia, Spain, 46014
    • H. General de Valencia
  • Zamora, Spain, 49022
    • H. Virgen de la Concha
  • Zaragoza, Spain, 50009
    • H. Miguel Servet
  • Zaragoza, Spain, 50009
    • H. Clínico Lozano Blesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with NVAF	Drug: Non-vitamin K antagonist oral anticoagulant; Non-vitamin K antagonist oral anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex	Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported.	At the single study visit (Day 1).
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex	Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported.	At the single study visit (Day 1).
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)	Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported.	At the single study visit (Day 1).
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical)	Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported.	At the single study visit (Day 1).
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure	Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported.	At the single study visit (Day 1).
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure	Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported.	At the single study visit (Day 1).
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease	Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported.	At the single study visit (Day 1).
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease	Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported.	At the single study visit (Day 1).
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes	Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported.	At the single study visit (Day 1).
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes	Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported.	At the single study visit (Day 1).
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease	Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported.	At the single study visit (Day 1).
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease	Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported.	At the single study visit (Day 1).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported.	At the single study visit (Day 1).
Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] Reported are Crcl values which are calculated according to: Cockcroft-Gault formula and CrCl values directly collected in the eCRF; Cockcroft-Gault formula only; Directly collected in the eCRF	At the single study visit (Day 1).
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	Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] The number of participants for each of the following creatinine clearance (CrCl) ranges is reported: CrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR); CrCl 60-89: Kidney damage with mild decreased GFR; CrCl 30-59: Moderate decrease in GFR; CrCl 15-29: Severe decrease in GFR; CrCl <15: Kidney failure	At the single study visit (Day 1).
Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.	At the single study visit (Day 1).
Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported.	At the single study visit (Day 1).
Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.	At the single study visit (Day 1).
Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported.	At the single study visit (Day 1).
Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported.	At the single study visit (Day 1).
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	Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels. For each reported laboratory parameter the values were categorized in two categories: Serum creatinine: Normal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females; High/low value ALT: Normal values: 7-55 units per liter (UI/L); High/low values AST: Normal values: 8-48 UI/L; High/low values Bilirubin: Normal values: 0.2-1.2 milligram per deciliter (mg/dl); High/low values Haemoglobin: Normal values: 12-18 gram/deciliter (g/dL); High/low values Platelets: Normal values: 150-450 x10^3/µL; High/low values	At the single study visit (Day 1).
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit. The date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for: All patients;; Patients treated previously with vitamin K antagonists (VKA);; Patients treated with NOAC as first anticoagulant .	At the single study visit (day 1).
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	NVAF was categorized in four categories: Persistent;; Long standing persistent;; Permanent;; Paroxysmal.	At the single study visit (day 1).
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	The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. The EHRA categories are the following: 1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued.	At the single study visit (day 1).
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	Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported.	At the single study visit (Day 1).
Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Coronary interventions were categorized in: Percutaneous coronary intervention and; Coronary artery bypass grafting.	At the single study visit (Day 1).
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	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 is reported. Heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories: No;; Yes.	At the single study visit (Day 1).
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	The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories: A - No objective evidence of cardiovascular disease; B - Objective evidence of minimal cardiovascular disease; C - Objective evidence of moderately severe cardiovascular disease; D - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported.	At the single study visit (Day 1).
Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records.	At the single study visit (Day 1).
Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.	At the single study visit (Day 1).
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	Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported. The comorbidities which were included in the Charlson Comorbidity Index were the following: Myocardial infarction; Congestive heart failure; Peripheral vascular disease; Cerebrovascular disease; Dementia; Chronic Obstructive Pulmonary Disease (COPD); Connective tissue disease; Peptic ulcer disease; Liver disease (No/Mild/Moderate to severe); Diabetes mellitus (No/Uncomplicated/End-organ damage); Hemiplegia; Moderate to severe renal disease; Solid Tumor (No/Localized/Metastatic); Leukaemia; Lymphoma; Acquired Immune Deficiency Syndrome (AIDS).	At the single study visit (Day 1).
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	Reported is the number of patients in each category of: Any history of thromboembolic events; Transient Ischemic Attack (TIA); Ischemic stroke; Haemorrhagic stroke; Embolism systemic; Deep vein thrombosis; Pulmonary embolism. Any history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories: No; Yes.	At the single study visit (Day 1).
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	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 non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Stable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories: Yes;; No.	At the single study visit (Day 1).
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	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 non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.	At the single study visit (Day 1).
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	Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported: Intracranial; Digestive; Genitourinary; Gingival; Nasal; Pulmonary; Articular-muscular; Conjunctival. Intracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories: No; Yes.	At the single study visit (Day 1).
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Total number of bleeding events and number of bleeding events for the following bleeding types is reported: Intracranial; Digestive; Genitourinary; Gingival; Nasal; Pulmonary; Articular-muscular; Conjunctival.	At the single study visit (Day 1).
CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (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.	At the single study visit (Day 1).
Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke: 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)	At the single study visit (Day 1).
HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding.	At the single study visit (Day 1).
Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type	The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk: Low risk (score 0); Intermediate risk (score 1-2); High risk (score ≥3)	At the single study visit (Day 1).
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	Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported. The concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following: Angiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor; Beta-blocker; Calcium channel blockers; Diuretics; Amiodarone; Statin; Proton pump inhibitor; H2-receptor antagonist; Digoxin; NSAIDs (Nonsteroidal Anti-Inflammatory Drugs); Dronedarone; Ketoconazole; Cyclosporine; Itraconazole; Other antiarrhythmics	At the single study visit (Day 1).
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	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 is reported. Previous VKA treatment was categorized in 2 categories: No;; Yes.	At the single study visit (Day 1).
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	Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation	Duration of treatment (in years) is reported for: All patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA); Patients treated only with the VKA warfarin (row: Warfarin patients); Patients treated only with the VKA acenocoumarol (row: Acenocoumarol patients)	At the single study visit (Day 1).
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	Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for: All patients; Patients treated previously with VKA; Patients treated only with NOAC as anticoagulant (AC)	At the single study visit (Day 1).
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation	Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
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	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 is reported.	At the single study visit (Day 1).
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation	Treatment duration (in years) is reported for: Patients who stopped first NOAC treatment;; Patients who did not stop the first NOAC treatment.	At the single study visit (Day 1).
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	Reason for first NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness; Investigator's decision; Patient's decision; Adverse event	At the single study visit (Day 1).
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	Reason for first NOAC treatment change was categorized in four categories: Lack of effectiveness; Investigator's decision; Patient's decision; Adverse event	At the single study visit (Day 1).
Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation	Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
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	Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported. Number of switches to a new NOAC was categorized in 3 categories: 0 switches; 1 switch; 2 switches.	At the single study visit (Day 1).
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation	Total number of switches according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation	Reason for switch was categorized in four categories: Lack of effectiveness; Investigator's decision; Patient's decision; Adverse event	At the single study visit (Day 1).
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation	Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
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	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 is reported.	At the single study visit (Day 1).
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation	Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
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	Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories: Lack of effectiveness; Investigator's decision; Patient's decision; Adverse event	At the single study visit (Day 1).
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	Reason for second NOAC treatment change was categorized in four categories: Lack of effectiveness; Investigator's decision; Patient's decision; Adverse event	At the single study visit (Day 1).
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation	Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
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	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 is reported.	At the single study visit (Day 1).
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation	Duration of third NOAC treatment for patients who stopped NOAC treatment.	At the single study visit (Day 1).
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	Reason for Third NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness; Investigator's decision; Patient's decision; Adverse event	At the single study visit (Day 1).
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	Reason for Third NOAC treatment change was categorized in four categories: Lack of effectiveness; Investigator's decision; Patient's decision; Adverse event	At the single study visit (Day 1).
Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation	Duration (in years) in NOAC treatment is reported for: All patients (patients who received or did not receive VKA); Patients treated previously with Vitamin K Antagonists (VKA); Patients treated with NOAC as first anticoagulant	At the single study visit (Day 1).
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	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 is reported. Total time in NOAC treatment was categorized in 4 categories: <1 year;; 1-2 years;; 2-3 years;; >3 years.	At the single study visit (Day 1).
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation	Number of patients for each type of following antiplatelet treatment that the patients ever received is reported: None (reports the patients who did not receive any antiplatelet treatment); Acetyl salicylic acid; Clopidogrel; Prasugrel; Ticlopidine; Ticagrelor; Cilostazol; Triflusal; Dipyridamole; Others (other antiplatelet treatment than above mentioned).	At the single study visit (Day 1).
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation	Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported: None (reports the patients who did not receive any antiplatelet treatment); Acetyl salicylic acid; Clopidogrel; Prasugrel; Ticlopidine; Ticagrelor; Cilostazol; Triflusal; Dipyridamole; Others (other antiplatelet treatment than above mentioned).	At the single study visit (Day 1).
Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation	Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported.	At the single study visit (Day 1).
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	Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score >4 was considered frail.	At the single study visit (Day 1).
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	Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. CFS was categorized in two categories, according to this ranges: Frailty patients - CFS scoring >4; Non-frailty patients - CFS scoring ≤4	At the single study visit (Day 1).
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	Reason for First NOAC usage was categorized in the following two categories: Primary prevention;; Secondary prevention.	At the single study visit (Day 1).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): August 20, 2020

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anticoagulants
• Other Study ID Numbers: 1160-0297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link: https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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