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
Study Type
OBSERVATIONAL
Enrollment
1,013
The vitamin K antagonists exert their anticoagulant effect through inhibition of the enzyme complex of vitamin K epoxide reductase subunit 1 with subsequent reduction of the gamma-carboxylation of certain glutamic acid molecules endpoints located on factors coagulation II (prothrombin), VII, IX and X and protein C or its cofactor protein S. This gamma-carboxylation has a significant bearing on the interaction of coagulation factors referenced with calcium ions. Without this reaction, blood clotting cannot be initiated. The dose must be adjusted to each patient at baseline and after regular basis, since the sensitivity to anticoagulants varies between individuals and can also vary throughout the treatment. For this, the Prothrombin Time (PT) is used and standardized ratio called International Normalised Ratio (INR).
Unnamed facility
Multiple Locations, Spain
International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
Percentage of time within an INR range of 2-3 estimated using the Rosendaal method
Time frame: Up to 24 months
Baseline thromboembolic risk based on the CHADS2 scale
CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
Time frame: Baseline
Baseline thromboembolic risk based on the CHA2DS2-VASc scale
CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category
Time frame: Baseline
Baseline haemorrhagic risk based on the HAS-BLED scale
HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol
Time frame: Baseline
Changes in INR time in therapeutic range
INR time in therapeutic range: percentage of time within an INR range of 2-3 estimated using the Rosendaal method
Time frame: Up to 24 months
Patient preferences with regard to anticoagulant treatment based on patients' questionnaires
Time frame: Up to 12 months
Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)
Time frame: Up to 12 months
Adherence to the anticoagulant treatment: Morisky-Green test
Time frame: Up to 12 months
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Number and type of visits by patients to health professionals related to their anticoagulant treatment
Time frame: Up to 12 months
Number of patients using anticoagulant treatment strategies
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
Time frame: 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
Time frame: Up to 24 months
Number of thromboembolic events in patients with inadequate anticoagulation management
Time frame: Up to 24 months
Number of haemorrhagic events in patients with inadequate anticoagulation management
Time frame: Up to 24 months