N/A
N=535
Health-related Quality of Life in Patients on Anticoagulants
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03134911 ↗Enrolled (actual)
535
Serious AEs
0.2%
Results posted
Apr 2019
Primary outcome: Primary: Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire — 4.9; 3.6; 4.3; 3.6 Unit on scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- DOAC or VKA (Drug); VKA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire |
4.9; 3.6; 4.3; 3.6; 3.1; 3.9 | — |
| SECONDARY Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
3; 40; 126; 2; 8; 79 | — |
| SECONDARY Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
163.1 | — |
| SECONDARY Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
76.5 | — |
| SECONDARY Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
28.7 | — |
| SECONDARY Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
57.2 | — |
| SECONDARY History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis |
2.5 | — |
| SECONDARY History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis |
77.3 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
56.1 | — |
| SECONDARY Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
87.0; 3.1; 6.2; 3.7 | — |
| SECONDARY CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
4.5 | — |
| SECONDARY HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
3.6 | — |
| SECONDARY Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories |
31.7; 28.3; 21.7; 8.3; 6.7; 6.7 | — |
| SECONDARY Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories |
68.0; 12.0; 4.0; 4.0; 4.0; 4.0 | — |
| SECONDARY Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
3.1 | — |
| SECONDARY Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
49.1; 35.0 | — |
| SECONDARY Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
14.8 | — |
| SECONDARY Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment |
97.7; 2.3 | — |
| SECONDARY The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases |
85.8; 48.5; 38.5; 34.3; 32.5; 19.5 | — |
| SECONDARY The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day |
72.5; 35.7; 33.9; 28.1; 25.1; 10.5 | — |
| SECONDARY The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment |
97.1; 2.9 | — |
Summary
The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study
Eligibility Criteria
Inclusion Criteria
- The patient is willing and provides written informed consent to participate in this study.
- The patient is at least 18 years of age
- The patient has a diagnosis of non-valvular atrial fibrillation
- The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.
- If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it.
Exclusion Criteria
- Current participation in any clinical trial of a drug or device
- Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).
Data sourced from ClinicalTrials.gov (NCT03134911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.