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Trial record 45 of 108 for:    CALCIUM CATION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02610153
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : April 25, 2019
Janssen Research & Development, LLC
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Vitamin K Antagonist

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Study Type : Observational
Actual Enrollment : 1013 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Group/Cohort Intervention/treatment
Cohort 1
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).

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02610153

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Multiple Locations, Spain
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer Identifier: NCT02610153     History of Changes
Other Study ID Numbers: 17943
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamin K
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action