Trial Condition(s):
Atrial Fibrillation
Subtherapeutic INR levels in patients with AVK: incidence, associated factors, prognosis and control strategies (SULTAN)
Bayer Identifier:
17943
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
1
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 methodTimeframe: Up to 24 months
Secondary Outcome
- Baseline thromboembolic risk based on the CHADS2 scaleCHADS2: Cardiac failure, Hypertension, Age, Diabetes, StrokeTimeframe: Baseline
- Baseline thromboembolic risk based on the CHA2DS2-VASc scaleCHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex categoryTimeframe: Baseline
- Baseline haemorrhagic risk based on the HAS-BLED scaleHAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcoholTimeframe: Baseline
- Changes in INR time in therapeutic rangeINR time in therapeutic range: percentage of time within an INR range of 2-3 estimated using the Rosendaal methodTimeframe: Up to 24 months
- Patient preferences with regard to anticoagulant treatment based on patients' questionnairesTimeframe: Up to 12 months
- Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)Timeframe: Up to 12 months
- Adherence to the anticoagulant treatment: Morisky-Green testTimeframe: Up to 12 months
- Number and type of visits by patients to health professionals related to their anticoagulant treatmentTimeframe: Up to 12 months
- Number of patients using anticoagulant treatment strategiesStrategies: 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 anticoagulantsTimeframe: Up to 24 months
- Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning reportTimeframe: Up to 24 months
- Number of thromboembolic events in patients with inadequate anticoagulation managementTimeframe: Up to 24 months
- Number of haemorrhagic events in patients with inadequate anticoagulation managementTimeframe: Up to 24 months
Additional Information
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