- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04297150
Predictive Factors for Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation..
Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Francisco Abad Santos, MD, PhD
- Phone Number: 915202425
- Email: francisco.abad@salud.madrid.org
Study Contact Backup
- Name: Gina Mejía Abril, MD
- Phone Number: 915202425
- Email: ginapaola.mejia@salud.madrid.org
Study Locations
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-
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Burgos, Spain, 09006
- Hospital Universitario de Burgos
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Madrid, Spain, 28034
- Hospital Universitario Ramon Y Cajal
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Madrid, Spain, 28006
- Hospital Universitario de La Princesa
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Madrid, Spain, 28046
- Hospital Universitario de La Paz
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Madrid, Spain, 28028
- Hospital Gómez Ulla
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Madrid, Spain, 28040
- Hospital Universitario Fundación Jiménez Díaz:
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients that satisfy inclusion criteria
Patients who satisfy the inclusion criteria and sign the informed consent.
|
Drug indicated for the treatment of NVAF
Other Names:
Drug indicated for the treatment of NVAF
Other Names:
Drug indicated for the treatment of NVAF
Other Names:
Drug indicated for the treatment of NVAF
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Throughout the follow-up, i.e. for at least 15 months and up to 30.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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..
|
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.
|
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.
|
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..
|
Throughout the follow-up, i.e. for at least 15 months and up to 30.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
- Dabigatran
- Apixaban
- Edoxaban
Other Study ID Numbers
- SFC-NAC-2019-01
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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