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Predictive Factors for Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation..

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ClinicalTrials.gov Identifier: NCT04297150
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Brief 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 (plasma concentrations), pharmacodynamic (haemostatic) and pharmacogenetic factors.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Apixaban Drug: Edoxaban Drug: Rivaroxaban Drug: Dabigatran

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).

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation.
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients that satisfy inclusion criteria
Patients who satisfy the inclusion criteria and sign the informed consent.
Drug: Apixaban
Drug indicated for the treatment of NVAF
Other Name: Eliquis

Drug: Edoxaban
Drug indicated for the treatment of NVAF
Other Name: Lixiana

Drug: Rivaroxaban
Drug indicated for the treatment of NVAF
Other Name: Xarelto

Drug: Dabigatran
Drug indicated for the treatment of NVAF
Other Name: Pradaxa




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Haemorragic stroke [ Time Frame: Throughout the follow-up, i.e. for at least 15 months and up to 30. ]
    Occurrence of haemorragic stroke will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..

  2. Ischemic stroke [ Time Frame: Throughout the follow-up, i.e. for at least 15 months and up to 30. ]
    Occurrence of ischemic stroke will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..

  3. Death [ Time Frame: Throughout the follow-up, i.e. for at least 15 months and up to 30. ]
    All-cause mortality will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..


Biospecimen Retention:   Samples With DNA
One tube of blood for DNA extration and genotyping. One tube of blood for plasma extraction and drug determination. One tube of blood for the determination of anticoagulant activity.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Men or women over 18 years of age
  2. Patients with non-valvular atrial fibrillation.
  3. 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 NVFA, according to the drug label.
  4. Patients who agree to participate in the study and give their written consent.

Exclusion Criteria:

  1. Pacientes en tratamiento con otros anticoagulantes.
  2. Pacientes que padezcan alguna enfermedad maligna o terminal cuya esperanza de vida sea inferior a 6 meses.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297150


Contacts
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Contact: Francisco Abad Santos, MD, PhD 915202425 francisco.abad@salud.madrid.org
Contact: Gina Mejía Abril, MD 915202425 ginapaola.mejia@salud.madrid.org

Locations
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Spain
Hospital Universitario de Burgos Recruiting
Burgos, Spain, 09006
Contact: Jorge Labrador Gómez, MD, PhD       jlabradorg@saludcastillayleon.es   
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Contact: Gina Paola Mejía, MD    915202425    ginapaola.mejia@salud.madrid.org   
Contact: Pablo Zubiaur Precioso, MPharm    915202425    pablo.zubiaur@salud.madrid.org   
Hospital Gómez Ulla Recruiting
Madrid, Spain, 28028
Contact: David Martí Sánchez, MD, PhD       docalcala@hotmail.com   
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: María Ángeles Gálvez Múgica, MD, PhD       mariaangeles.galvez@salud.madrid.org   
Hospital Universitario Fundación Jiménez Díaz: Not yet recruiting
Madrid, Spain, 28040
Contact: Lucia Llanos Jiménez, MD, PhD       lucia.llanos@fjd.es   
Hospital Universitario de La Paz Recruiting
Madrid, Spain, 28046
Contact: Irene García García, MD       irene.ucicec@gmail.com   
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT04297150    
Other Study ID Numbers: SFC-NAC-2019-01
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Apixaban
Edoxaban
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants