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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    700
  • sponsor
    Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Updated on 26 January 2021
stroke
anticoagulants
rivaroxaban
fibrillation
apixaban
edoxaban
dabigatran
embolism

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.

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 Ramn y Cajal, Fundacin Jimnez Daz, Hospital Gmez 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).

Details
Condition Arrhythmia, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment Rivaroxaban, Apixaban, Dabigatran, Edoxaban
Clinical Study IdentifierNCT04297150
SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men or women over 18 years of age
Patients with non-valvular atrial fibrillation
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
Patients who agree to participate in the study and give their written consent

Exclusion Criteria

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