Atrial FibrillationRE-CONOCENCT03285373
This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 75 sites in Spain.
Trial summary
The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- NOAC
- Type of treatment
- Pill or oral medicine
- How many people
- 1,008 participants
- Where
- 75 sitesSpain
- Study dates
- 29 Nov 2017to 31 Jan 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -if the current participating patient participate in any clinical trial of a drug or device will be excluded
Trial locations and contacts
75 sites in 1 country.
75 sites in 1 country
Spain75 sites
Clínica Modelo
A Coruña, 15011
Hospital Universatio de Albacete
Albacete, 2006
Hospital Quirónsalud Sur
Alcorcón (Madrid), 28922
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Dr. José Molina Orosa
Arrecife, Las Palmas, 35500
H de Cabueñes
Asturias, 33394
Hospital Infanta Cristina
Badajoz, 06080
Clínica Sagrada Familia
Barcelona, 08022
Medical Practice
Barcelona, 08037
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
H. del Mar
Barcelona, 8003
Hospital del Mar
Barcelona, 8003
H. Residencia Sant Camil
Barcelona, 8810
H. Moisés Broggi
Barcelona, 8970
Hospital Basurto
Bilbao, 48013
H Aranda Duero
Burgos, 9400
Hospital de Cáceres
Cáceres, 10004
Medical Practice
Castellon, 12540
Medical Practice
Córdoba, 14005
Medical Practice
Córdoba, 14006
Centro Médico Puerto
El Puerto de Santa Maria (Cádiz), 11500
Hospital General de Elche
Elche (Alicante), 03202
Hospital Vinalopo Salud
Elche (Alicante), 03293
Hospital García Orcoyen
Estella (Navarra), 31200
Clínica Del Río Estepona y San Pedro
Estepona (Málaga), 29680
Complejo Hospitalario Arquitecto Marcide
Ferrol (A Coruña), 15405
Hospital Galdakao
Galdakao (Vizcaya), 48960
Medical Practice
Gandía (Valencia), 46702
Hospital Vithas La Salud
Granada, 18008
Medical Practice
Granada, 18012
Medical Practice
Granollers (Barcelona), 08402
H. U. Guadalajara
Guadalajara, 19002
Hospital Universitario de Bellvitge
Hospitalet de Ll (Barcelona), 08907
Hospital Juan Ramon Jiménez
Huelva, 21005
Medical Practice
Huesca, 22005
H. Universitario Dr. Negrín
Las Palmas, 35010
Hospital General San Agustin
Linares (Jaen), 23700
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital de la Princesa
Madrid, 28006
Hospital Nuestra Señora del Rosario
Madrid, 28006
Hospital Gregorio Marañon
Madrid, 28009
Hospital Fundación Jiménez Díaz
Madrid, 28040
H. Quirón Salud H. Sur Alcorcón
Madrid, 28922
Hospital Universitario Puerta del Hierro
Majadahonda (Madrid), 28222
Hospital de Manises
Manises (Valencia), 36940
Hospital Ochoa
Marbella (Málaga), 29602
Hospital de Mataró
Mataró (Barcelona), 08304
Hospital de Mérida
Mérida, 6800
Hospital Universitario Central de Asturias
Oviedo (Asturias), 33011
Hospital de Son Llatzer
Palma de Mallorca (Baleares), 07198
Hospital Quirón Campo de Gibraltar
Palmones (Cádiz), 11379
Centro de Especialidades Dr. San Martin
Pamplona, 31004
Complejo Hospitalario de Pontevedra
Pontevedra, 36078
Hospital Universitari Parc Taulí
Sabadell (Barcelona), 08208
H. C. U. Salamanca
Salamanca, 37007
Policlínic Sant Cugat
Sant Cugat Del Valles (Barcelona), 08172
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, 38010
Complejo H. Universitario de Canarias
Santa Cruz de Tenerife, 38302
CH Santiago de Compostela
Santiago de Compostela (A Coruña), 15706
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela (A Coruña), 15706
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela (A Coruña), 15706
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Duque del Infantado
Seville, 41012
Medical Practice
Seville, 41013
Hospital Santa Santa Bárbara
Soria, 42005
Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43005
HM Hospitales Madrid
Torrelodones (Madrid), 28250
Clínica Santa Elena
Torremolinos, 29620
Pius Hospital de Valls
Valls (Tarragona), 43800
Hospital Universitari de La Plana
Vila-Real (Castellón), 12540
Hospital Lluis Alcanyis
Xàtiva (Valencia), 46800
Complejo Asistencial de Zamora
Zamora, 49022
H. Clínico Universitario
Zaragoza, 50009
H. Miguel Servet
Zaragoza, 50009
H. Royo Villanova
Zaragoza, 50015
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- NOAC
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOACDrug
New Oral Anticoagulant
| Study group | Role | What they receive |
|---|---|---|
| patients with NVAF | patients with Non Valvular Atrial Fibrillation Receives: Drug: NOAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.
Measured: Start of the first NOAC treatment
Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation.
The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Measured: Start of the first NOAC treatment
Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation.
The total CHA2DS2-VASc Scores score was stratified by category according to the following classification:
- Low risk (score 0 in male; score 1 in female)
- Moderate risk (score 1 in male; score 2 in female)
- High risk (score ≥2 in male; score ≥3 in female)
Measured: Start of the first NOAC treatment
Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.
Measured: Start of the first NOAC treatment
Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation
Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation.
The total HAS-BLED Score was stratified by category according to the following classification:
- Low risk (score 0)
- Moderate risk (score 1-2)
- High risk (score ≥3)
Measured: Start of the first NOAC treatment
Secondary outcomes (9)
Appropriateness of NOACs Prescription
Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met.
Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.
Measured: single visit (Day 1)
Mean Number of Visits to the Physician Per Year
Mean number of visits to the physician per year considered for the NOAC Management.
Measured: 1 year (data collected during single visit on day 1)
Duration of First NOAC, All NOAC and Subsequent NOAC Treatment
Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).
Measured: 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
Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC
Measured: single visit (Day 1)
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose
Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.
Measured: single visit (Day 1)
Reason for Treatment Changes
Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.
Measured: Start of the first NOAC treatment
Number of Patients With Previous Treatment With Vitamin K Antagonists
Number of patient with Previous Treatment with Vitamin K Antagonists.
Measured: single visit (Day 1)
Duration of Previous VKA Treatment
Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC
Measured: Through the observational period with an average of 43.8 months, data collected during a single visit.
Patient's Knowledge About His Condition
At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed.
Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?
Measured: single visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start29 Nov 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mireia Canals, +34607550925, Study chair, mireia.canals@boehringer-ingelheim.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285373
- Sponsor's protocol ID
- 1160-0287
- Acronym
- RE-CONOCE
- Status last verified
- Feb 2020
- First submitted
- 14 Sep 2017
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional, Cross-sectional Study to Describe NOACs Management ss in Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.
- ClinicalTrials.gov ID
- NCT03285373
- Acronym / sponsor ID
- RE-CONOCE / 1160-0287
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with NVAF | – | Drug: NOACpatients with Non Valvular Atrial Fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -if the current participating patient participate in any clinical trial of a drug or device will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOACNew Oral Anticoagulant | Drug | patients with NVAF |
Primary outcome
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.
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.
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)
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.
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)
9 secondary outcomes
Appropriateness of NOACs Prescription
Time frame: 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)
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.
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 Changed From One NOAC to a New NOAC Type and Dose
Time frame: single visit (Day 1)
Reason for Treatment Changes
Time frame: Start of the first NOAC treatment
Number of Patients With Previous Treatment With Vitamin K Antagonists
Time frame: 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.
Patient's Knowledge About His Condition
Time frame: single visit (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireia Canals, +34607550925 study chair
mireia.canals@boehringer-ingelheim.com
75 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 75 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation (time frame: Start of the first NOAC treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.