check_circleStudy Completed
Atrial Fibrillation
Bayer Identifier:
17943
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
1013Trial Dates
October 2015 - March 2019Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 methoddate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Baseline thromboembolic risk based on the CHADS2 scaleCHADS2: Cardiac failure, Hypertension, Age, Diabetes, Strokedate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Baseline thromboembolic risk based on the CHA2DS2-VASc scaleCHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex categorydate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Baseline haemorrhagic risk based on the HAS-BLED scaleHAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcoholdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- 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 methoddate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Patient preferences with regard to anticoagulant treatment based on patients' questionnairesdate_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)date_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- Adherence to the anticoagulant treatment: Morisky-Green testdate_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- Number and type of visits by patients to health professionals related to their anticoagulant treatmentdate_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- 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 anticoagulantsdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning reportdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of thromboembolic events in patients with inadequate anticoagulation managementdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionYesSafety Issue:
- Number of haemorrhagic events in patients with inadequate anticoagulation managementdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A