check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

17943

ClinicalTrials.gov Identifier:

NCT02610153

EudraCT Number:

Not Available

EU CT Number:

Not Available
Subtherapeutic INR levels in patients with AVK: incidence, associated factors, prognosis and control strategies

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.


  • - 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.

Trial summary

Enrollment Goal
1013
Trial Dates
October 2015 - March 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain

Primary Outcome

  • International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
    Percentage of time within an INR range of 2-3 estimated using the Rosendaal method
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Baseline thromboembolic risk based on the CHADS2 scale
    CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Baseline thromboembolic risk based on the CHA2DS2-VASc scale
    CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Baseline haemorrhagic risk based on the HAS-BLED scale
    HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Changes in INR time in therapeutic range
    INR time in therapeutic range: percentage of time within an INR range of 2-3 estimated using the Rosendaal method
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Patient preferences with regard to anticoagulant treatment based on patients' questionnaires
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Adherence to the anticoagulant treatment: Morisky-Green test
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Number and type of visits by patients to health professionals related to their anticoagulant treatment
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients using anticoagulant treatment strategies
    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
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning report
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of thromboembolic events in patients with inadequate anticoagulation management
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of haemorrhagic events in patients with inadequate anticoagulation management
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Prospective Observational Study Assessing the Management of Anticoagulation with Vitamin K Antagonists in Patients with Nonvalvular Atrial Fibrillation Treated in Cardiology Practices
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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