Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Treatments: Vitamin K; Vitamins

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.