Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment vitamin k antagonist
Sponsor Bayer
Collaborator Janssen Research & Development, LLC
Start date October 2015
End date May 2018
Trial size 1000 participants
Trial identifier NCT02610153, 17943

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
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).

Primary Outcomes

Measure
International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
time frame: At 6 months visit
INR Time in Therapeutic Range (TTR)
time frame: At 12 months visit

Secondary Outcomes

Measure
Baseline thromboembolic risk based on the CHADS2 scale
time frame: Baseline
Baseline thromboembolic risk based on the CHA2DS2-VASc scale
time frame: Baseline
Baseline haemorrhagic risk based on the HAS-BLED scale
time frame: Baseline
Changes in INR time in therapeutic range
time frame: At 6 months visit, at 12 months visit
Patient preferences with regard to anticoagulant treatment based on patients' questionnaires
time frame: At 12 months visit
Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)
time frame: At 12 months visit
Adherence to the anticoagulant treatment: Morisky-Green test
time frame: At 6 months visit, at 12 months visit
Number and type of visits by patients to health professionals related to their anticoagulant treatment
time frame: At 6 months visit, at 12 months visit
Number of patients using anticoagulant treatment strategies
time frame: At 6 months visit, at 12 months visit
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: At initiation visit, at 6 months visit, at 12 months visit
Number of thromboembolic events in patients with inadequate anticoagulation management
time frame: At 6 months visit, at 12 months visit
Number of haemorrhagic events in patients with inadequate anticoagulation management
time frame: At 6 months visit, at 12 months visit

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.