Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
- 试验地点
- 6
- 主要终点
- Major haemorrhages
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients on treatment with other anticoagulants.
- •Patients suffering from a malignant or terminal disease whose life expectancy is less than 6 months.
研究组 & 干预措施
Patients that satisfy inclusion criteria
Patients who satisfy the inclusion criteria and sign the informed consent.
干预措施: Apixaban (Drug)
Patients that satisfy inclusion criteria
Patients who satisfy the inclusion criteria and sign the informed consent.
干预措施: Edoxaban (Drug)
Patients that satisfy inclusion criteria
Patients who satisfy the inclusion criteria and sign the informed consent.
干预措施: Rivaroxaban (Drug)
Patients that satisfy inclusion criteria
Patients who satisfy the inclusion criteria and sign the informed consent.
干预措施: Dabigatran (Drug)
结局指标
主要结局
Major haemorrhages
时间窗: 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.
次要结局
- 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.)