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.
1 other identifier
observational
700
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
June 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJune 6, 2023
June 1, 2023
3.3 years
February 18, 2020
June 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Haemorragic stroke
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.
Death
Throughout the follow-up, i.e. for at least 15 months and up to 30.
Study Arms (1)
Patients that satisfy inclusion criteria
Patients who satisfy the inclusion criteria and sign the informed consent.
Interventions
Drug indicated for the treatment of NVAF
Drug indicated for the treatment of NVAF
Drug indicated for the treatment of NVAF
Drug indicated for the treatment of NVAF
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients on treatment with other anticoagulants.
- Patients suffering from a malignant or terminal disease whose life expectancy is less than 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Gómez Ulla
Madrid, 28028, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundación Jiménez Díaz:
Madrid, 28040, Spain
Hospital Universitario de La Paz
Madrid, 28046, Spain
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
March 5, 2020
Study Start
June 18, 2020
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
June 6, 2023
Record last verified: 2023-06