Clinical trial NCT02610153: Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies
Official title: A Prospective Observational Study Assessing the Management of Anticoagulation With Vitamin K Antagonists in Patients With Nonvalvular Atrial Fibrillation Treated in Cardiology Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2015-11-20
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Baseline thromboembolic risk based on the CHADS2 scale
timeFrame: Baseline
measure: Baseline thromboembolic risk based on the CHA2DS2-VASc scale
timeFrame: Baseline
measure: Baseline haemorrhagic risk based on the HAS-BLED scale
timeFrame: Baseline
measure: Changes in INR time in therapeutic range
timeFrame: Up to 24 months
measure: Patient preferences with regard to anticoagulant treatment based on patients' questionnaires
timeFrame: Up to 12 months
measure: Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)
timeFrame: Up to 12 months
measure: Adherence to the anticoagulant treatment: Morisky-Green test
timeFrame: Up to 12 months
measure: Number and type of visits by patients to health professionals related to their anticoagulant treatment
timeFrame: Up to 12 months
measure: Number of patients using anticoagulant treatment strategies
timeFrame: Up to 24 months
measure: Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning report
timeFrame: Up to 24 months
measure: Number of thromboembolic events in patients with inadequate anticoagulation management
timeFrame: Up to 24 months
measure: Number of haemorrhagic events in patients with inadequate anticoagulation management
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: