NCT07458191招募中不适用
Monitoring Safety and Therapeutic Adherence During Anticoagulant Prophylaxis With Apixa® in Patients With Nonvalvular Atrial Fibrillation (Praćenje Sigurnosti i Terapijske Adherence u Toku Antikoagulantne Profilakse Lijekom Apixa® Kod Pacijenata sa Nevalvularnom Atrijalnom Fibrilacijom)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Composite primary outcome including incidence of major bleeding and clinically relevant non-major bleeding
研究概览
简要总结
The aim of this observational study is to evaluate safety and therapeutic adherence during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation. The main questions it aims to answer are:
- What is the incidence of major bleeding and clinically relevant non-major bleeding during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation?
- What is therapy adherence during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation?
- What is frequency and types of other adverse reactions, excluding bleeding, during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation? Participants will be followed for six months through four measurements. The first and fourth measurements will be performed in person, while the remaining measurements can also be recorded by telephone, if the patient's condition allows. Any bleeding or serious adverse reactions to the medication being administered will be recorded immediately, through unscheduled measurements. Adverse reactions will be recorded at each measurement. Adherence to the medication being administered will be evaluated using the BARS scale.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Hemodynamically stable patients.
- •Patients with non-valvular atrial fibrillation.
- •Patients in whom the investigator, based on clinical assessment makes a decision to introduce apixaban therapy.
- •Patients who are on apixaban therapy for the first time
排除标准
- •Positive history of angioneurotic edema.
- •Active, clinically significant bleeding.
- •Congenital or acquired bleeding disorder.
- •The presence of a malignant tumor.
- •Current or recent presence of gastrointestinal ulcer.
- •The presence of established or suspected esophageal varices.
- •Positive history of arteriovenous malformations, vascular aneurysms or intraspinal and intracerebral vascular anomalies.
- •Patients with artificial heart valves.
- •Liver cirrhosis and active liver disease associated with coagulopathy and clinically significant risk of bleeding.
- •Dialysis patients (GFR <15 ml/min).
- •Simultaneous use of other anticoagulants.
- •Pregnancy and breastfeeding.
- •Patients who previously used apixaban in therapy.
- •Withdrawal Criteria:
- •Deterioration of the clinical picture of the underlying disease that requires discontinuation of investigational therapy.
- •Development of serious adverse events that require discontinuation of therapy.
- •Occurrence of pregnancy.
- •Development of another disease that affects the course of research.
研究组 & 干预措施
Apixaban
Patients with nonvalvular atrial fibrillation receiving apixaban therapy
干预措施: Apixaban (Drug)
结局指标
主要结局
Composite primary outcome including incidence of major bleeding and clinically relevant non-major bleeding
时间窗: From enrollment to the end of study after six months
The primary outcome will be bleeding, composed of major bleeding reported according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and non-major bleeding including prolonged bleeding from cuts on the skin, bleeding from gums or nose, blood in the stool and/or urine, vomiting and/or coughing up blood, and prolonged or heavier menstruation.
次要结局
- Monitoring the composite outcome of major, clinically relevant non-major and minor bleeding(From enrollment to the end of study after six months)
- Monitoring the frequency and type of other adverse reactions, excluding bleeding(From enrollment to the end of study after six months)
- Monitoring of adherence to anticoagulant prophylaxis(From enrollment to the end of study after six months)
研究者
研究点 (1)
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