Atrial Fibrillation
Conditions
Brief summary
To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.
Interventions
DRUGPradaxa®
Dabigatran etexilate
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort A (patients switched from VKA to Pradaxa) * Written informed consent prior to participation. * Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF). * At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment. * Patients switched to Pradaxa prior to baseline assessment according to the physician's discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria. OR Cohort B (patients newly initiated Pradaxa or VKA) * Written informed consent prior to participation. * Female or male patients ≥ 20 years of age, newly diagnosed with NVAF, and no previous treatment for stroke prevention (no use of any OAC within 1 year prior to enrolment). * Patients initiated stroke prevention treatment with Pradaxa or VKA according to the physician's discretion and the SmPCs/reimbursement criteria.
Exclusion criteria
* Contraindication to the use of Pradaxa® or VKA as described in the SmPCs. * Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF. * Current participation in any clinical trial of a drug or device. * Current participation in an AF-related registry, e.g. the Gloria AF program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®). | The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA). | The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®). | The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). |
| Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Baseline | The PACT-Q1 was composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/Completely/Very much). |
Countries
Taiwan
Participant flow
Recruitment details
This non-interventional study enrolled patients in Taiwan with a previous Vitamin K Antagonist (VKA) therapy, followed by switching to Pradaxa® (one of the novel oral anticoagulants (NOACs)) or patients being newly diagnosed with Non-Valvular Atrial Fibrillation (NVAF) and initiated on Pradaxa® or VKA.
Pre-assignment details
Data was collected from approximately 20 medical centers or regional hospitals in Taiwan where Pradaxa® is taken as the prescription of stroke prophylaxis (or prevention) in Atrial Fibrillation (AF). Data was collected between June 23, 2017 and Jan 11, 2019. 10 enrolled participants were removed due to screening failures before entering the study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily. | 139 |
| Cohort B - Pradaxa® Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily. | 1,052 |
| Cohort B - VKA Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician. | 54 |
| Total | 1,245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problem | 1 | 1 | 0 |
| Overall Study | Adverse Event | 6 | 29 | 0 |
| Overall Study | Death | 0 | 11 | 0 |
| Overall Study | Lost to Follow-up | 1 | 60 | 7 |
| Overall Study | Missing | 1 | 32 | 3 |
| Overall Study | NA in incl/excl criteria, not analyzed. | 14 | 45 | 1 |
| Overall Study | Reason not listed | 2 | 54 | 1 |
| Overall Study | Status missing | 2 | 33 | 3 |
| Overall Study | Stopped Pradaxa®/VKA | 11 | 65 | 4 |
| Overall Study | Withdrawal by Subject | 8 | 63 | 4 |
Baseline characteristics
| Characteristic | Cohort A | Cohort B - Pradaxa® | Cohort B - VKA | Total |
|---|---|---|---|---|
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 15.65 | 71.5 Years STANDARD_DEVIATION 13.08 | 67.1 Years STANDARD_DEVIATION 12.88 | 71.0 Years STANDARD_DEVIATION 13.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants | 1052 Participants | 54 Participants | 1245 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 139 Participants | 1052 Participants | 54 Participants | 1245 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 57 Participants | 431 Participants | 17 Participants | 505 Participants |
| Sex: Female, Male Male | 82 Participants | 621 Participants | 37 Participants | 740 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 11 / 978 | 0 / 48 |
| other Total, other adverse events | 0 / 148 | 0 / 978 | 0 / 48 |
| serious Total, serious adverse events | 1 / 148 | 4 / 978 | 0 / 48 |
Outcome results
Primary
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison.
Time frame: Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Convenience - Visit 2 | 92.4 Units on Scale | Standard Deviation 9.88 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Convenience - Visit 3 | 93.9 Units on Scale | Standard Deviation 8.41 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Satisfaction - Visit 2 | 70.1 Units on Scale | Standard Deviation 11.51 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Satisfaction - Visit 3 | 73.9 Units on Scale | Standard Deviation 12.05 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | PSM Convenience - Visit 2 | 98.5 Units on Scale | Standard Deviation 2.18 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | PSM Satisfaction - Visit 2 | 71.4 Units on Scale | Standard Deviation 0 |
| Cohort B - VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | PSM Convenience - Visit 2 | 80.8 Units on Scale | Standard Deviation 9.79 |
| Cohort B - VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Convenience - Visit 2 | 94.3 Units on Scale | Standard Deviation 5.61 |
| Cohort B - VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Satisfaction - Visit 3 | 75.1 Units on Scale | Standard Deviation 11.95 |
| Cohort B - VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Convenience - Visit 3 | 94.3 Units on Scale | Standard Deviation 6.35 |
| Cohort B - VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | PSM Satisfaction - Visit 2 | 64.3 Units on Scale | Standard Deviation 2.02 |
| Cohort B - VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Pre-PSM Satisfaction - Visit 2 | 67.3 Units on Scale | Standard Deviation 9.17 |
Comparison: Between group comparison of Visit 2 treatment convenience before PSM.p-value: 0.7879t-test, 2 sided
Comparison: Between group comparison of Visit 3 treatment convenience before PSM.p-value: 0.611t-test, 2 sided
Comparison: Between group comparison of Visit 2 treatment satisfaction before PSM.p-value: 0.0832t-test, 2 sided
Comparison: Between group comparison of Visit 3 treatment satisfaction before PSM.p-value: 0.6488t-test, 2 sided
Comparison: Between group comparison of Visit 2 treatment convenience after PSM.p-value: 0.1301Two sample T test
Comparison: Between group comparison of Visit 2 treatment satisfaction after PSM.p-value: 0.1257Two sample T test
Primary
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Time frame: Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Convenience - Baseline | 86.9 Units on Scale | Standard Deviation 13.31 |
| Cohort A | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Convenience - Visit 2 | 91.7 Units on Scale | Standard Deviation 10.74 |
| Cohort A | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Convenience - Visit 3 | 95.2 Units on Scale | Standard Deviation 6.48 |
| Cohort A | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Satisfaction - Baseline | 64.3 Units on Scale | Standard Deviation 11.06 |
| Cohort A | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Satisfaction - Visit 2 | 68.1 Units on Scale | Standard Deviation 13.36 |
| Cohort A | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Satisfaction - Visit 3 | 72.5 Units on Scale | Standard Deviation 12.41 |
Comparison: Within group comparison of Baseline convenience with that of Visit 2.p-value: 0.0001Paired t-test
Comparison: Within group comparison of Baseline convenience with that of Visit 3.p-value: 0.0001Paired t-test
Comparison: Within group comparison of Baseline satisfaction with that of Visit 2.p-value: 0.0031Paired t-test
Comparison: Within group comparison of Baseline satisfaction with that of Visit 3.p-value: 0.0001Paired t-test
Secondary
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
The PACT-Q1 was composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/Completely/Very much).
Time frame: Baseline
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q2 | 3.2 Units on scale | Standard Deviation 1.19 |
| Cohort A | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q4 | 3.6 Units on scale | Standard Deviation 1.15 |
| Cohort A | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q1 | 3.2 Units on scale | Standard Deviation 1.13 |
| Cohort A | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q5 | 2.8 Units on scale | Standard Deviation 1.42 |
| Cohort A | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q3 | 2.3 Units on scale | Standard Deviation 1.09 |
| Cohort A | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q6 | 3.7 Units on scale | Standard Deviation 1.12 |
| Cohort A | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q7 | 2.4 Units on scale | Standard Deviation 1.39 |
| Cohort B - VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q6 | 3.7 Units on scale | Standard Deviation 1.09 |
| Cohort B - VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q7 | 1.9 Units on scale | Standard Deviation 1.21 |
| Cohort B - VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q1 | 3.0 Units on scale | Standard Deviation 0.99 |
| Cohort B - VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q2 | 3.1 Units on scale | Standard Deviation 1.11 |
| Cohort B - VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q3 | 2.1 Units on scale | Standard Deviation 1 |
| Cohort B - VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q4 | 3.7 Units on scale | Standard Deviation 1.21 |
| Cohort B - VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Q5 | 2.7 Units on scale | Standard Deviation 1.54 |
Secondary
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Time frame: Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Convenience - Visit 2 | 91.7 Units on scale | Standard Deviation 10.74 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Convenience - Visit 3 | 95.2 Units on scale | Standard Deviation 6.48 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Satisfaction - Visit 2 | 68.1 Units on scale | Standard Deviation 13.36 |
| Cohort A | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Satisfaction - Visit 3 | 72.5 Units on scale | Standard Deviation 12.41 |