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

Atrial Fibrillation Clinical Trial

Official title:

Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04297150
• Other study ID #: SFC-NAC-2019-01
• Status: Active, not recruiting
• Start date: June 18, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Men or women over 18 years of age

2. Patients with non-valvular atrial fibrillation (NVAF).

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 NVAF, according to the drug label.

4. Patients who agree to participate in the study and give their written consent.

Exclusion Criteria:

1. Patients on treatment with other anticoagulants.

2. Patients suffering from a malignant or terminal disease whose life expectancy is less than 6 months.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
Drug indicated for the treatment of NVAF
• Edoxaban
Drug indicated for the treatment of NVAF
• Rivaroxaban
Drug indicated for the treatment of NVAF
• Dabigatran
Drug indicated for the treatment of NVAF

Locations

Country	Name	City	State
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Gómez Ulla	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz:	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major haemorrhages	Occurrence of haemorrhages will be monitored throughout the follow-up, i.e. for at least 15 months and up to 30.	Throughout the follow-up, i.e. for at least 15 months and up to 30.
Secondary	Haemorragic stroke	Occurrence of haemorragic stroke will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..	Throughout the follow-up, i.e. for at least 15 months and up to 30.
Secondary	Ischemic stroke	Occurrence of ischemic stroke will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..	Throughout the follow-up, i.e. for at least 15 months and up to 30.
Secondary	Death	All-cause mortality will be monitored throughout the follow-up i.e. for at least 15 months and up to 30..	Throughout the follow-up, i.e. for at least 15 months and up to 30.