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Completed

NCT Number: NCT02610153

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin K antagonist

Drug

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

  1. International Normalized Ratio (INR) Time in Therapeutic Range (TTR)

    Time frame: Up to 24 months

    Percentage of time within an INR range of 2-3 estimated using the Rosendaal method

Secondary outcomes

  1. Baseline thromboembolic risk based on the CHADS2 scale

    Time frame: Baseline

    CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke

  2. Baseline thromboembolic risk based on the CHA2DS2-VASc scale

    Time frame: Baseline

    CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category

  3. Baseline haemorrhagic risk based on the HAS-BLED scale

    Time frame: Baseline

    HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol

  4. Changes in INR time in therapeutic range

    Time frame: Up to 24 months

    INR time in therapeutic range: percentage of time within an INR range of 2-3 estimated using the Rosendaal method

  5. Patient preferences with regard to anticoagulant treatment based on patients' questionnaires

    Time frame: Up to 12 months

  6. Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)

    Time frame: Up to 12 months

  7. Adherence to the anticoagulant treatment: Morisky-Green test

    Time frame: Up to 12 months

  8. Number and type of visits by patients to health professionals related to their anticoagulant treatment

    Time frame: Up to 12 months

  9. Number of patients using anticoagulant treatment strategies

    Time frame: Up to 24 months

    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

  10. 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

  11. Number of thromboembolic events in patients with inadequate anticoagulation management

    Time frame: Up to 24 months

  12. Number of haemorrhagic events in patients with inadequate anticoagulation management

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

A Prospective Observational Study Assessing the Management of Anticoagulation With Vitamin K Antagonists in Patients With Nonvalvular Atrial Fibrillation Treated in Cardiology Practices

Acronym: SULTAN

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Nov 20, 2015
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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