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

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (Other)

Overall Status

Recruiting

CT.gov ID

NCT04297150

Collaborator

(none)

700

Enrollment

Locations

28.4

Anticipated Duration (Months)

116.7

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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).

Study Design

Study Type:

Observational

Anticipated 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 :

Jun 18, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	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 Names: Eliquis Drug: Edoxaban Drug indicated for the treatment of NVAF Other Names: Lixiana Drug: Rivaroxaban Drug indicated for the treatment of NVAF Other Names: Xarelto Drug: Dabigatran Drug indicated for the treatment of NVAF Other Names: Pradaxa

Arm

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 Names:

Eliquis

Drug: Edoxaban

Drug indicated for the treatment of NVAF

Other Names:

Lixiana

Drug: Rivaroxaban

Drug indicated for the treatment of NVAF

Other Names:

Xarelto

Drug: Dabigatran

Drug indicated for the treatment of NVAF

Other Names:

Pradaxa

Outcome Measures

Primary Outcome Measures

Major haemorrhages [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

Haemorragic stroke [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..
Ischemic stroke [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..
Death [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..

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

Patients on treatment with other anticoagulants.
Patients suffering from a malignant or terminal disease whose life expectancy is less than 6 months.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital Universitario de Burgos	Burgos	Spain	09006
2	Hospital Universitario de La Princesa	Madrid	Spain	28006
3	Hospital Gómez Ulla	Madrid	Spain	28028
4	Hospital Universitario Ramón y Cajal	Madrid	Spain	28034
5	Hospital Universitario Fundación Jiménez Díaz:	Madrid	Spain	28040
6	Hospital Universitario de La Paz	Madrid	Spain	28046