Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies
- Registration Number
- NCT02610153
- Lead Sponsor
- Bayer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1013
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Vitamin K Antagonist 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
- Primary Outcome Measures
Name Time Method International Normalized Ratio (INR) Time in Therapeutic Range (TTR) Up to 24 months Percentage of time within an INR range of 2-3 estimated using the Rosendaal method
- Secondary Outcome Measures
Name Time Method Baseline thromboembolic risk based on the CHADS2 scale Baseline CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
Baseline thromboembolic risk based on the CHA2DS2-VASc scale Baseline CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category
Baseline haemorrhagic risk based on the HAS-BLED scale Baseline HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol
Changes in INR time in therapeutic range Up to 24 months INR time in therapeutic range: percentage of time within an INR range of 2-3 estimated using the Rosendaal method
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 Strategies: patients continuing vitamin K antagonists, patients with changes/adjustments to the dose of vitamin K antagonists and patients whose treatment is changed to direct action oral anticoagulants
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