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

NCT03993119 | Completed Results FDA Drug

• 1 other identifier: 1160-0297
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 45

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (60)

• Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type

  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

  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

  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

  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

  At the single study visit (Day 1).

Study Arms (1)

patients with NVAF

Drug: Non-vitamin K antagonist oral anticoagulant

Interventions

Non-vitamin K antagonist oral anticoagulant DRUG

Non-vitamin K antagonist oral anticoagulant

patients with NVAF

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (45)

H. Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Consulta Privada

Almería, 4630, Spain

Location

H. Dr. José Molina Orosa

Arrecife, Las Palmas, 35500, Spain

Location

Centro Médico San Juan de Dios

Barakaldo, Bizkaia, 48901, Spain

Location

H. Sagrat Cor

Barcelona, 8029, Spain

Location

H. Vall d'Hebron

Barcelona, 8035, Spain

Location

H. Sant Pau

Barcelona, 8041, Spain

Location

H. Vithas Internacional Xanit

Benalmádena, Málaga, 29631, Spain

Location

Ambulatorio Txurdinaga

Bilbao, 48004, Spain

Location

H. San Juan de Dios de Bormujos

Bormujos, Sevilla, 41930, Spain

Location

H. Provincial de Castellón

Castellon, 12002, Spain

Location

H. San Pedro Alcántara

Cáceres, 10003, Spain

Location

Consulta privada Dr. Ruiz

Córdoba, 14006, Spain

Location

H. Arquitecto Marcide

Ferrol, A Coruña, 15405, Spain

Location

H. de Jaen

Jaén, 23007, Spain

Location

H. U. de León

León, 24008, Spain

Location

H. Arnau de Vilanova

Lleida, 25198, Spain

Location

H. Lucus Augusti

Lugo, 27003, Spain

Location

H. La Princesa

Madrid, 28006, Spain

Location

Sanitas La Zarzuela

Madrid, 28023, Spain

Location

H. Central de la Defensa Gómez

Madrid, 28047, Spain

Location

H. Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

H. de Mataró

Mataró, Barcelona, 8304, Spain

Location

Consulta Privada

Málaga, 29002, Spain

Location

H. de Mendaro

Mendaro, Guipúzcoa, 20850, Spain

Location

H. Morales Meseguer

Murcia, 30008, Spain

Location

H. Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Consulta privada Merelles Otero

Ourense, 32003, Spain

Location

Consulta Privada

Ourense, 32003, Spain

Location

H. Río Carrión

Palencia, 34005, Spain

Location

H. Son Llatzer

Palma de Mallorca, 7198, Spain

Location

H. de Navarra

Pamplona, 31008, Spain

Location

H. Comarcal de la Vega Baja

San Bartolomé, Alicante, 3314, Spain

Location

H. Moises Broggi

Sant Joan Despí, Barcelona, 8970, Spain

Location

H. Marqués de Valdecilla

Santander, 39008, Spain

Location

H. Álvarez-Buylla

Santullano, Asturias, 33619, Spain

Location

H. Virgen de la Macarena

Seville, 41009, Spain

Location

H. Virgen del Valle

Toledo, 45071, Spain

Location

H. de Torrejón

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Consulta Privada

Valencia, 46005, Spain

Location

H. General de Valencia

Valencia, 46014, Spain

Location

Hospital La Fe

Valencia, 46026, Spain

Location

H. Virgen de la Concha

Zamora, 49022, Spain

Location

H. Clínico Lozano Blesa

Zaragoza, 50009, Spain

Location

H. Miguel Servet

Zaragoza, 50009, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

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, (+34) 93 404 58 77

  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: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 20, 2019
• Study Start: July 30, 2019
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: September 29, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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'.

Locations

ES (45)