An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-25.
Sponsored by Bayer · Observational
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
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 1,013 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients diagnosed with non-valvular atrial fibrillation who are going to start vitamine K antagonist treatment or have started over the previous two months and that attend the Cardiology Units at Spanish hospitals (as outpatients).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Drug: Vitamin K Antagonist
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).
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
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
Ran from Oct 2015 to primary completion in Jun 2018, 32 months.
Of 149 industry-sponsored observational studies under Atrial Fibrillation, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 32 months is above that.
Counting every sponsor, half of 685 studies reached it within 38 months; a quarter within 22 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.