Prospective, National, Multicentric, Observational Study to Evaluate the Safety, Efficacy and Quality of Life of Patients With Atrial Fibrillation, Treated With Trombix® (Rivaroxaban).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 398
- 试验地点
- 17
- 主要终点
- Assessment of reported Serious Adverse Effects linked to Trombix ®
研究概览
简要总结
The rational behind this observational study is to collect real life data about the use of Trombix® (Rivaroxaban) among patients with atrial fibrillation in Algeria . The aim is to evaluate the safety, efficacy and quality of life.
详细描述
Trombix® (Rivaroxaban) is used for the treatment of patients with atrial fibrillation. BEKER laboratories are conducting an observation study to evaluate its use among Algerian population in regards to its safety, efficacy and the quality of life of patients after its use.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, aged ≥ 19 years.
- •Patient with a diagnosis of atrial fibrillation who requires treatment with Trombix® or switch of Anti-Vitamin K treatment toTrombix® (patient not balanced with current treatment or wishing to change treatment with better manageability).
- •Patient being able to provide free and informed written consent before the study.
排除标准
- •Hypersensitivity to the active ingredient or to one of the excipients indicated in the Summary of Product Characteristics of Trombix®
- •Clinically significant progressive bleeding.
- •Injury or illness, if considered to be at significant risk of major bleeding. This may include: current or recent gastrointestinal ulceration, presence of malignant tumors with a high risk of bleeding, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intra-spinal or intracerebral vascular anomalies.
- •Concomitant treatment with any other anticoagulant, for example, unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran exilate, apixaban, etc.) except in specific circumstances of switching from anticoagulant treatment or in the case of administration of UFH at doses necessary to maintain the permeability of a central venous or arterial catheter.
- •Liver injury associated with coagulopathy and clinically significant bleeding risk, including cirrhotic patients with Child Pugh score class B or C.
- •Pregnancy and breast feeding
研究组 & 干预措施
Patients with confirmed diagnosis of Atrial fibrillation
male, female, 19 or more of age with confirmed diagnosis of Atrial fibrillation
干预措施: Trombix® (Rivaroxaban) (Drug)
结局指标
主要结局
Assessment of reported Serious Adverse Effects linked to Trombix ®
时间窗: 12 months
* Assessment of serious adverse effects "major bleeding" linked to Trombix® reported as per the current medical practice for the following: * Incidence of intracranial hemorrhages * Incidence of hemorrhages requiring hospitalization with transfusion * Incidence of fatal hemorrhages * Incidence of critical organ bleeding * Incidence of gastrointestinal bleeding
次要结局
- Incidence of any adverse effects(12 months)
- Minor hemorrhages linked to Trombix®(12 months)
- Epidemiological profile of patients: demographic data, pathological history, clinical profile at inclusion(12 months)
- Incidence of Trombix® treatment interruptions during 12 months of follow-up(12 months)
- Quality of life score(12 months)
- Relative risk linked to each cause for stopping the treatment with Trombix® during follow-up(12 months)
- Incidence of severe thromboses: ischemic stroke / MI / non CNS-Systemic embolism(12 months)