NCT02610153已完成不适用
A Prospective Observational Study Assessing the Management of Anticoagulation With Vitamin K Antagonists in Patients With Nonvalvular Atrial Fibrillation Treated in Cardiology Practices
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,013
- 主要终点
- International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
研究概览
简要总结
This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life clinical practice and to explore the effectiveness and safety of these strategies in patients with non-valvular atrial fibrillation who start vitamin K antagonist (VKA) treatment
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 aged ≥ 18 years.
- •Patients with a diagnosis of nonvalvular atrial fibrillation according to the criteria of the Spanish Agency of Medicines and Medical Devices (AEMPS) (2013) who are treated in cardiology practices.
- •Patients about to start treatment with a vitamin K antagonist or who are in the first two months of treatment.
- •Patients for whom access to at least 80% of INR tests performed during treatment with vitamin K antagonists is expected to be available.
- •Patients with the mental and physical capacity to complete the study questionnaires and give their informed consent to participate in the study.
排除标准
- •Patients with mitral stenosis or another significant valve disease for which specific treatment is scheduled or has already been performed (prosthesis or valvuloplasty).
- •Patients hospitalised at the time of inclusion in the study.
- •Patients with a life expectancy of less than 13 months.
- •Patients who are participating in a clinical trial.
- •Patients receiving double antiplatelet therapy.
研究组 & 干预措施
Cohort 1
Adult patients, diagnosed with no-valvular atrial fibrillation and who have recently initiated or are going to initiate VKA treatment, that attend the Cardiology Units
干预措施: Vitamin K Antagonist (Drug)
结局指标
主要结局
International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
时间窗: Up to 24 months
Percentage of time within an INR range of 2-3 estimated using the Rosendaal method
次要结局
- Baseline thromboembolic risk based on the CHADS2 scale(Baseline)
- Baseline thromboembolic risk based on the CHA2DS2-VASc scale(Baseline)
- Baseline haemorrhagic risk based on the HAS-BLED scale(Baseline)
- Changes in INR time in therapeutic range(Up to 24 months)
- Patient preferences with regard to anticoagulant treatment based on patients' questionnaires(Up to 12 months)
- Adherence to the anticoagulant treatment: Morisky-Green test(Up to 12 months)
- Number and type of visits by patients to health professionals related to their anticoagulant treatment(Up to 12 months)
- Number of patients using anticoagulant treatment strategies(Up to 24 months)
- Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning report(Up to 24 months)
- Number of thromboembolic events in patients with inadequate anticoagulation management(Up to 24 months)
- Number of haemorrhagic events in patients with inadequate anticoagulation management(Up to 24 months)
- Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)(Up to 12 months)
研究者
相似试验
尚未招募
不适用
A study to determine the rate of occurrence of pain caused due to nerve damage after surgery in patients with bone and soft tissue cancer.CTRI/2021/04/032709Tata Memorial Hospital
已完成
不适用
The Impact of Past Coronavirus Disease 19 (COVID-19) Infection on the Live Birth Rates of Frozen Embryo Transfer CyclesCOVID-19Frozen Embryo TransferNCT05739019ShangHai Ji Ai Genetics & IVF Institute820
已完成
不适用
Prospective observational risk-analysis of the incidence and severity of pressure ulcers and wound infections in obese patients in the ICU.NL-OMON29677Investigator initiated1,175
尚未招募
不适用
Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI TechnologyChronic Obstructive Pulmonary DiseaseNCT05774730China-Japan Friendship Hospital40
尚未招募
Unknown
A prospective observational study on the evaluation of coagulation function of contrast medium-mixed blood using the blood coagulation analysis device TEG 6s.Patients under general anesthesia with an arterial line inserted during surgery.JPRN-UMIN000052805Tohoku University100