Atrial FibrillationNCT04297150
Predictive Factors for Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation..
An observational study of Atrial Fibrillation, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 6 sites in Spain.
Trial summary
Post-authorization observational, prospective, follow-up study of a cohort of patients with non-valvular atrial fibrillation who are treated with direct oral anticoagulants (DOACs) to evaluate the clinical course (occurrence of stroke, major bleeding and mortality) and its correlation with clinical, pharmacokinetic… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Apixaban, Edoxaban and Rivaroxaban
- How many people
- 700 participants
- Where
- 6 sitesSpain
- Study dates
- 18 Jun 2020to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women over 18 years of age with NVAF requiring anticoagulant treatment with a DOAC. The prescription of the treatment will be previous and independent to the inclusion of the patient in the study. Patients who will initiate treatment (which will only be evaluated prospectively) and patients already in treatment (which will also be evaluated retrospectively) will be included.
Who may be able to join
- Men or women over 18 years of age
- Patients with non-valvular atrial fibrillation (NVAF).
- Patients who are going to receive or are receiving treatment with any of the DOACs (dabigatran, rivaroxaban, apixaban or edoxaban) for the prevention of stroke and systemic embolism in adult patients with NVAF, according to the drug label.
- Patients who agree to participate in the study and give their written consent.
Who cannot join
- Patients on treatment with other anticoagulants.
- Patients suffering from a malignant or terminal disease whose life expectancy is less than 6 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitario de Burgos
Burgos, 09006
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Gómez Ulla
Madrid, 28028
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Fundación Jiménez Díaz:
Madrid, 28040
Hospital Universitario de La Paz
Madrid, 28046
About this study
Official title: Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation.
Post-authorization observational, prospective, follow-up study of a cohort of patients with non-valvular atrial fibrillation who are treated with direct oral anticoagulants (DOACs) to evaluate the clinical course (occurrence of stroke, major bleeding and mortality) and its correlation with clinical, pharmacokinetic (plasma concentrations), pharmacodynamic (haemostatic) and pharmacogenetic factors.
Read the detailed description
Post-authorization observational, prospective, follow-up study of a cohort of patients with non-valvular atrial fibrillation treated with direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban) to assess the clinical course (occurrence of stroke, other ischemic or bleeding events and mortality) and its correlation with clinical, pharmacokinetic (plasma concentrations), pharmacodynamic (haemostatic) and pharmacogenetic factors.
Patient selection and follow-up will be performed in 6 public Spanish hospitals: Hospital Universitario de la Princesa, Hospital Universitario La Paz, Hospital Universitario Ramón y Cajal, Fundación Jiménez Díaz, Hospital Gómez Ulla (Madrid) and Hospital Universitario de Burgos (Burgos). To reduce variability, the determination of anticoagulant activity will be performed in the Hematology Service of the Hospital Universitario de Burgos and the measurement of plasma concentrations and genotyping of all patients in the Clinical Pharmacology Service of the Hospital Universitario de la Princesa.
Patients who are to receive or are receiving one of the four DOACs currently available in Spain will be informed about the characteristics of this study and will be asked to sign the consent form for their participation. The treatment or clinical management of these patients at each centre will not be modified. They will be asked three blood samples, coinciding with other tests that will be carried out to monitor their pathology (one blood sample for the study of the effect on coagulation, another for drug quantification in plasma and another for genetic studies) with the only requirement that they must have been treated with the drug for at least one week so that they have spent more than 5 half-lives and are in steady state. The samples will be extracted in the morning, before medication intake (trough concentrations).
- Conditions
- Atrial Fibrillation
- Being tested
- Apixaban, Edoxaban, Rivaroxaban, Dabigatran
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
Drug indicated for the treatment of NVAF
EdoxabanDrug
Also called Lixiana
Drug indicated for the treatment of NVAF
RivaroxabanDrug
Also called Xarelto
Drug indicated for the treatment of NVAF
DabigatranDrug
Also called Pradaxa
Drug indicated for the treatment of NVAF
| Study group | Role | What they receive |
|---|---|---|
| Patients that satisfy inclusion criteria | Patients who satisfy the inclusion criteria and sign the informed consent. Receives: Drug: Apixaban; Drug: Edoxaban; Drug: Rivaroxaban; Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major haemorrhages
Occurrence of haemorrhages will be monitored throughout the follow-up, i.e. for at least 15 months and up to 30.
Measured: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Secondary outcomes (3)
Haemorragic stroke
Occurrence of haemorragic stroke will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..
Measured: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Ischemic stroke
Occurrence of ischemic stroke will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..
Measured: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Death
All-cause mortality will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..
Measured: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start18 Jun 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297150
- Sponsor's protocol ID
- SFC-NAC-2019-01
- Status last verified
- Jun 2023
- First submitted
- 18 Feb 2020
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT04297150
- Acronym / sponsor ID
- SFC-NAC-2019-01
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-authorization observational, prospective, follow-up study of a cohort of patients with non-valvular atrial fibrillation who are treated with direct oral anticoagulants (DOACs) to evaluate the clinical course (occurrence of stroke, major bleeding and mortality) and its correlation with clinical, pharmacokinetic (plasma concentrations), pharmacodynamic (haemostatic) and pharmacogenetic factors.
Detailed description
Post-authorization observational, prospective, follow-up study of a cohort of patients with non-valvular atrial fibrillation treated with direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban) to assess the clinical course (occurrence of stroke, other ischemic or bleeding events and mortality) and its correlation with clinical, pharmacokinetic (plasma concentrations), pharmacodynamic (haemostatic) and pharmacogenetic factors.
Patient selection and follow-up will be performed in 6 public Spanish hospitals: Hospital Universitario de la Princesa, Hospital Universitario La Paz, Hospital Universitario Ramón y Cajal, Fundación Jiménez Díaz, Hospital Gómez Ulla (Madrid) and Hospital Universitario de Burgos (Burgos). To reduce variability, the determination of anticoagulant activity will be performed in the Hematology Service of the Hospital Universitario de Burgos and the measurement of plasma concentrations and genotyping of all patients in the Clinical Pharmacology Service of the Hospital Universitario de la Princesa.
Patients who are to receive or are receiving one of the four DOACs currently available in Spain will be informed about the characteristics of this study and will be asked to sign the consent form for their participation. The treatment or clinical management of these patients at each centre will not be modified. They will be asked three blood samples, coinciding with other tests that will be carried out to monitor their pathology (one blood sample for the study of the effect on coagulation, another for drug quantification in plasma and another for genetic studies) with the only requirement that they must have been treated with the drug for at least one week so that they have spent more than 5 half-lives and are in steady state. The samples will be extracted in the morning, before medication intake (trough concentrations).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients that satisfy inclusion criteria | – | Drug: Apixaban, Drug: Edoxaban, Drug: Rivaroxaban, Drug: DabigatranPatients who satisfy the inclusion criteria and sign the informed consent. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women over 18 years of age with NVAF requiring anticoagulant treatment with a DOAC. The prescription of the treatment will be previous and independent to the inclusion of the patient in the study. Patients who will initiate treatment (which will only be evaluated prospectively) and patients already in treatment (which will also be evaluated retrospectively) will be included.
Key inclusion criteria (4 listed)
- Men or women over 18 years of age
- Patients with non-valvular atrial fibrillation (NVAF).
- Patients who are going to receive or are receiving treatment with any of the DOACs (dabigatran, rivaroxaban, apixaban or edoxaban) for the prevention of stroke and systemic embolism in adult patients with NVAF, according to the drug label.
- Patients who agree to participate in the study and give their written consent.
Key exclusion criteria (2 listed)
- Patients on treatment with other anticoagulants.
- Patients suffering from a malignant or terminal disease whose life expectancy is less than 6 months.
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 |
|---|---|---|
| ApixabanAlso: EliquisDrug indicated for the treatment of NVAF | Drug | Patients that satisfy inclusion criteria |
| EdoxabanAlso: LixianaDrug indicated for the treatment of NVAF | Drug | Patients that satisfy inclusion criteria |
| RivaroxabanAlso: XareltoDrug indicated for the treatment of NVAF | Drug | Patients that satisfy inclusion criteria |
| DabigatranAlso: PradaxaDrug indicated for the treatment of NVAF | Drug | Patients that satisfy inclusion criteria |
Primary outcome
Major haemorrhages
Time frame: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Occurrence of haemorrhages will be monitored throughout the follow-up, i.e. for at least 15 months and up to 30.
3 secondary outcomes
Haemorragic stroke
Time frame: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Ischemic stroke
Time frame: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Death
Time frame: Throughout the follow-up, i.e. for at least 15 months and up to 30.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 6 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 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
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?
Major haemorrhages (time frame: Throughout the follow-up, i.e. for at least 15 months and up to 30.). 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 6 Jun 2023.