Trial Outcomes & Findings for Health-related Quality of Life in Patients on Anticoagulants (NCT NCT03134911)
NCT ID: NCT03134911
Last Updated: 2019-04-18
Results Overview
Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score.
COMPLETED
535 participants
The study consisted of a single visit between April 2017 and January 2018
2019-04-18
Participant Flow
This was an observational, multicentre and cross-sectional study conducted in Departments of Internal Medicine from 47 sites in Spain. The patient received the same anticoagulant treatment for at least 6 months and no more than 2 years.
Data were obtained from a single visit that coincided with one of those performed by the patients as part of routine follow-up of their disease, without interfering with usual clinical practice of the investigator. 535 patients were enrolled and 34 excluded from analysis due to being screening failure and not meeting inclusion/ exclusion criteria.
Participant milestones
| Measure |
Total Patients With Non-valvular Atrial Fibrillation
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment with uncontrolled anticoagulation status and VKA or direct oral anticoagulant (DOAC) treatment with controlled anticoagulation status were included. For both the groups treatment were given for at least 6 months and up to 2 years.
|
|---|---|
|
Overall Study
STARTED
|
535
|
|
Overall Study
COMPLETED
|
501
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Total Patients With Non-valvular Atrial Fibrillation
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment with uncontrolled anticoagulation status and VKA or direct oral anticoagulant (DOAC) treatment with controlled anticoagulation status were included. For both the groups treatment were given for at least 6 months and up to 2 years.
|
|---|---|
|
Overall Study
Screen failure
|
31
|
|
Overall Study
Not meeting inclusion/exclusion criteria
|
3
|
Baseline Characteristics
Ethnicity was not reported for this trial.
Baseline characteristics by cohort
| Measure |
Uncontrolled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
Controlled Group
n=330 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.4 Years
STANDARD_DEVIATION 8.7 • n=171 Participants
|
79.3 Years
STANDARD_DEVIATION 8.8 • n=330 Participants
|
79.7 Years
STANDARD_DEVIATION 8.7 • n=501 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=171 Participants
|
152 Participants
n=330 Participants
|
247 Participants
n=501 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=171 Participants
|
178 Participants
n=330 Participants
|
254 Participants
n=501 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 Participants
Ethnicity was not reported for this trial.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
0 Participants
Ethnicity was not reported for this trial.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
Ethnicity was not reported for this trial.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=171 Participants
|
0 Participants
n=330 Participants
|
0 Participants
n=501 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=171 Participants
|
0 Participants
n=330 Participants
|
0 Participants
n=501 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=171 Participants
|
0 Participants
n=330 Participants
|
0 Participants
n=501 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=171 Participants
|
0 Participants
n=330 Participants
|
0 Participants
n=501 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=171 Participants
|
330 Participants
n=330 Participants
|
501 Participants
n=501 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=171 Participants
|
0 Participants
n=330 Participants
|
0 Participants
n=501 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=171 Participants
|
0 Participants
n=330 Participants
|
0 Participants
n=501 Participants
|
PRIMARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) with uncontrolled anticoagulation status and those with controlled anticoagulation status receiving VKA or direct oral anticoagulant (DOAC) treatment at least 6 months and up to 2 years were included.
Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score.
Outcome measures
| Measure |
Controlled Group
n=330 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
Treatment satisfaction
|
4.9 Unit on scale
Standard Deviation 1.0
|
3.6 Unit on scale
Standard Deviation 1.3
|
|
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
Self-efficacy
|
4.3 Unit on scale
Standard Deviation 1.0
|
3.6 Unit on scale
Standard Deviation 1.0
|
|
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
Distress
|
3.1 Unit on scale
Standard Deviation 0.9
|
3.9 Unit on scale
Standard Deviation 1.1
|
|
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
Daily hassles
|
2.1 Unit on scale
Standard Deviation 0.8
|
3.0 Unit on scale
Standard Deviation 1.0
|
|
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
Strained social network
|
1.8 Unit on scale
Standard Deviation 0.9
|
2.6 Unit on scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Age group, work status and life status of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Work status - Employed
|
3 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Work status - Housewife
|
40 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Work status - Retired
|
126 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Work status - Other
|
2 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Life status - Single
|
8 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Life status - Married
|
79 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Life status - Widowed
|
78 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Life status - Divorced
|
6 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Age < 65
|
10 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Age 65 - 75
|
32 Participants
|
—
|
|
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Age ≥ 75
|
129 Participants
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.
Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Outcome measures
| Measure |
Controlled Group
n=142 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
163.1 Centimeter (cm)
Standard Deviation 8.8
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.
Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Outcome measures
| Measure |
Controlled Group
n=144 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
76.5 Kilogram (kg)
Standard Deviation 16.1
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.
BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Outcome measures
| Measure |
Controlled Group
n=142 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
28.7 Kilogram/meter^2 (kg/m^2)
Standard Deviation 5.4
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.
Kidney function of uncontrolled non-valvular atrial fibrillation (NVAF) patients measured by creatinine clearance is presented.
Outcome measures
| Measure |
Controlled Group
n=150 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
57.2 Millilitre/minute (ml/min)
Standard Deviation 26.6
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Analysis of data regarding the specific NVAF profile of uncontrolled patients indicated that the average (± SD) time since diagnosis (calculated as the time from the date of diagnosis to the date of the baseline visit).
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis
|
2.5 Years
Standard Deviation 3.2
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Age at diagnosis of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis
|
77.3 Years
Standard Deviation 8.7
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Left ventricular ejection fraction (LVEF) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Outcome measures
| Measure |
Controlled Group
n=108 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
56.1 Percentage (%)
Standard Deviation 11.2
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Percentage of patients with left ventricular ejection fraction (LVEF) depression (% of LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively.
Outcome measures
| Measure |
Controlled Group
n=161 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Normal (≥ 50%)
|
87.0 Percentage of patients (%)
|
—
|
|
Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Slightly depressed (41-49%)
|
3.1 Percentage of patients (%)
|
—
|
|
Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Moderately depressed (31-40%)
|
6.2 Percentage of patients (%)
|
—
|
|
Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Severely depressed (≤ 30%)
|
3.7 Percentage of patients (%)
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
4.5 Unit on scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (\>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
3.6 Unit on scale
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of thromboembolic events by categories are presented.
Outcome measures
| Measure |
Controlled Group
n=60 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Non-ST segment elevation myocardial infarction
|
31.7 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Cerebral infarction
|
28.3 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
TIA
|
21.7 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Pulmonary embolism
|
8.3 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Stable angina pectoris
|
6.7 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
ST-segment elevation myocardial infarction
|
6.7 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Unstable angina
|
6.7 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Deep vein thrombosis
|
5.0 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
Systemic embolism
|
1.7 Percentage of patients (%)
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of haemorrhagic events by categories are presented.
Outcome measures
| Measure |
Controlled Group
n=25 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Gastrointestinal
|
68.0 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Genitourinary
|
12.0 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Pulmonary
|
4.0 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Articular-muscular
|
4.0 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Intracranial
|
4.0 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Conjunctival
|
4.0 Percentage of patients (%)
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
Nasal
|
4.0 Percentage of patients (%)
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Number of visits to the internal medicine specialist per year of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
3.1 Visits per year
Standard Deviation 1.9
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Therapeutic time in range (TTR%) of uncontrolled non-valvular atrial fibrillation (NVAF) patients determined by the Rosendaal method (poor control \< 65%) or by the direct method (poor control \< 60%).
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
Rosendaal method (poor control < 65%)
|
49.1 Percentage (%)
Standard Deviation 10.8
|
—
|
|
Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
The direct method (poor control < 60%)
|
35.0 Percentage (%)
Standard Deviation 15.2
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Time since treatment initiation of uncontrolled non-valvular atrial fibrillation (NVAF) patients was calculated as the time from the start date of treatment to the date of the baseline visit.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
|
14.8 Months
Standard Deviation 6.3
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients received type VKA treatment is presented.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment
Acenocoumarol
|
97.7 Percentage of patients (%)
6.3
|
—
|
|
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment
Warfarin
|
2.3 Percentage of patients (%)
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with at least one other concomitant diseases recorded in the medical history.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Hypertension
|
85.8 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Congestive heart failure
|
48.5 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Diabetes mellitus
|
38.5 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Renal failure
|
34.3 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Anaemia
|
32.5 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Arterial vascular disease
|
19.5 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Previous stroke/transient ischaemic attack (TIA)
|
17.8 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Venous thromboembolism
|
4.7 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Liver failure
|
1.8 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
Other
|
33.1 Percentage of patients (%)
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with active concomitant diseases on visit day. The percentage was calculated on total patients who presented each of the diseases.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Hypertension
|
72.5 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Congestive heart failure
|
35.7 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Diabetes mellitus
|
33.9 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Kidney failure
|
28.1 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Anaemia
|
25.1 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Arterial vascular disease
|
10.5 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Previous stroke/TIA
|
7.6 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Liver failure
|
1.2 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Venous thromboembolism
|
0.6 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
Other
|
23.4 Percentage of patients (%)
|
—
|
SECONDARY outcome
Timeframe: The study consisted of a single visit between April 2017 and January 2018Population: All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with concomitant treatment is presented.
Outcome measures
| Measure |
Controlled Group
n=171 Participants
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
Uncontrolled Group
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
|---|---|---|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment
Yes
|
97.1 Percentage of patients (%)
|
—
|
|
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment
No
|
2.9 Percentage of patients (%)
|
—
|
Adverse Events
Uncontrolled Group
VKA Controlled Group
DOAC Controlled Group
Serious adverse events
| Measure |
Uncontrolled Group
n=171 participants at risk
Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.
|
VKA Controlled Group
n=69 participants at risk
Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
DOAC Controlled Group
n=261 participants at risk
Patients with non-valvular atrial fibrillation (NVAF), who received direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.
|
|---|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/171 • Adverse events collected during the study period between April 2017 and January 2018; up to 41 weeks
|
0.00%
0/69 • Adverse events collected during the study period between April 2017 and January 2018; up to 41 weeks
|
0.38%
1/261 • Adverse events collected during the study period between April 2017 and January 2018; up to 41 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER