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

February 7, 2020 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1008

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Ramon 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 Clínico 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with NVAF
patients with Non Valvular Atrial Fibrillation
Drug: NOAC
New Oral Anticoagulant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
Time Frame: Start of the first NOAC treatment
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
Time Frame: Start of the first NOAC treatment

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
Time Frame: Start of the first NOAC treatment

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:

  1. Low risk (score 0 in male; score 1 in female)
  2. Moderate risk (score 1 in male; score 2 in female)
  3. 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
Time Frame: Start of the first NOAC treatment
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
Time Frame: Start of the first NOAC treatment

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:

  1. Low risk (score 0)
  2. Moderate risk (score 1-2)
  3. High risk (score ≥3)
Start of the first NOAC treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Appropriateness of NOACs Prescription
Time Frame: single visit (Day 1)

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
Time Frame: 1 year (data collected during single visit on day 1)
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
Time Frame: 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.
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
Time Frame: single visit (Day 1)
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
Time Frame: single visit (Day 1)
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
Time Frame: Start of the first NOAC treatment
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
Time Frame: single visit (Day 1)
Number of patient with Previous Treatment with Vitamin K Antagonists.
single visit (Day 1)
Duration of Previous VKA Treatment
Time Frame: Through the observational period with an average of 43.8 months, data collected during a single visit.
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
Time Frame: single visit (Day 1)

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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