Atrial Fibrillation
Conditions
Brief summary
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).
Interventions
DRUGPradaxa (dabigatran)
Pradaxa (dabigatran etexilate)110mg or 150mg
Vitamin K antagonist or Pradaxa
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort A: 1. A. Written informed consent prior to participation 2. A. Female and male patients \>= 18 years of age with a diagnosis of non-valvular atrial fibrillation. 3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment. 4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion. OR Cohort B: 1. B. Written informed consent prior to participation. 2. B. Female and male patients \>= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment). 3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.
Exclusion criteria
1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC). 2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation. 3. Current participation in any clinical trial of a drug or device. 4. Current participation in an European registry on the use of oral anticoagulation in AF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A | Baseline (Visit1) | Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A) |
| Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment | Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) | Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis. |
| Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment | Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA) | Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis. |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups | Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) | Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis. |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups | Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) | Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. |
| Patient Characterization at Baseline - Categorical Parameters | Baseline (Visit1) | Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score | Baseline (Visit1) | HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. |
| Patient Characteristics at Baseline - Creatinine Clearance | Baseline (Visit1) | Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics. |
| Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) | Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 score. |
| Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | Baseline (Visit1) | For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively. The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation. The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much). |
| Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score | Baseline (Visit1) | 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. |
Countries
Indonesia, Malaysia, Singapore, South Korea, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A (Switch Patients - Pradaxa) Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa. | 379 |
| Cohort B (New Patients - Pradaxa) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa | 591 |
| Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician. | 343 |
| Total | 1,313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 67 | 36 |
| Overall Study | No inform. on termination of Pradaxa/VKA | 6 | 10 | 1 |
| Overall Study | Other adverse event | 36 | 41 | 8 |
| Overall Study | Other, reason not specified | 14 | 29 | 25 |
| Overall Study | Withdrawal by Subject | 6 | 17 | 12 |
| Overall Study | Worsening of disease under study | 1 | 1 | 1 |
| Overall Study | Worsening of other pre-existing disease | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Cohort B (New Patients - Pradaxa) | Cohort A (Switch Patients - Pradaxa) | Cohort B (New Patients - VKA) |
|---|---|---|---|---|
| Age, Continuous | 67.0 Years STANDARD_DEVIATION 10.2 | 67.3 Years STANDARD_DEVIATION 9.8 | 69.7 Years STANDARD_DEVIATION 9 | 63.4 Years STANDARD_DEVIATION 10.9 |
| Age, Customized >= 65 and < 75 Year | 511 Participants | 256 Participants | 154 Participants | 101 Participants |
| Age, Customized < 65 Years | 475 Participants | 196 Participants | 95 Participants | 184 Participants |
| Age, Customized >= 75 Years | 327 Participants | 139 Participants | 130 Participants | 58 Participants |
| Baseline creatinine clearance category <30 mL/min | 13 Participants | 0 Participants | 0 Participants | 13 Participants |
| Baseline creatinine clearance category 30 to <50 mL/min | 159 Participants | 66 Participants | 64 Participants | 29 Participants |
| Baseline creatinine clearance category 50 to <80 mL/min | 414 Participants | 210 Participants | 126 Participants | 78 Participants |
| Baseline creatinine clearance category >=80 mL/min | 278 Participants | 140 Participants | 69 Participants | 69 Participants |
| Baseline creatinine clearance category Missing | 449 Participants | 175 Participants | 120 Participants | 154 Participants |
| CHA2DS2-VASc score High risk (score ≥2) | 1000 Participants | 482 Participants | 331 Participants | 187 Participants |
| CHA2DS2-VASc score Intermediate risk (score=1) | 227 Participants | 78 Participants | 43 Participants | 106 Participants |
| CHA2DS2-VASc score Low risk (score=0) | 84 Participants | 29 Participants | 5 Participants | 50 Participants |
| CHA2DS2-VASc score Missing | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| HAS-BLED score High risk (score ≥3) | 174 Participants | 49 Participants | 88 Participants | 37 Participants |
| HAS-BLED score Low risk (score <3) | 1137 Participants | 540 Participants | 291 Participants | 306 Participants |
| HAS-BLED score Missing | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Owner of medical practice Community health center | 10 Participants | 5 Participants | 3 Participants | 2 Participants |
| Owner of medical practice Health Maintenance Organisation (HMO) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Owner of medical practice Medical / academic health center | 531 Participants | 231 Participants | 156 Participants | 144 Participants |
| Owner of medical practice Other | 68 Participants | 44 Participants | 24 Participants | 0 Participants |
| Owner of medical practice Other health care corporation | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Owner of medical practice Other hospital | 100 Participants | 43 Participants | 22 Participants | 35 Participants |
| Owner of medical practice Physician or physician group | 604 Participants | 268 Participants | 174 Participants | 162 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment Korea, Republic Of Non-South Korea | 210 Participants | 124 Participants | 54 Participants | 32 Participants |
| Region of Enrollment Korea, Republic Of South Korea | 1103 Participants | 467 Participants | 325 Participants | 311 Participants |
| Sex: Female, Male Female | 464 Participants | 228 Participants | 130 Participants | 106 Participants |
| Sex: Female, Male Male | 849 Participants | 363 Participants | 249 Participants | 237 Participants |
| Speciality of treating physician Cardiologist | 1257 Participants | 572 Participants | 362 Participants | 323 Participants |
| Speciality of treating physician General practitioner | 4 Participants | 3 Participants | 0 Participants | 1 Participants |
| Speciality of treating physician Other specialist | 52 Participants | 16 Participants | 17 Participants | 19 Participants |
| Type of hospital or practice Other | 44 Participants | 27 Participants | 8 Participants | 9 Participants |
| Type of hospital or practice Private | 710 Participants | 309 Participants | 200 Participants | 201 Participants |
| Type of hospital or practice Public | 559 Participants | 255 Participants | 171 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 379 | 0 / 591 | 0 / 343 |
| other Total, other adverse events | 0 / 379 | 0 / 591 | 0 / 343 |
| serious Total, serious adverse events | 5 / 379 | 1 / 591 | 6 / 343 |
Outcome results
Primary
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment
Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.
Time frame: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment | Convenience dimension score: Baseline | 71.4 Unit on scale | Standard Deviation 21.8 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment | Convenience dimension score: Last assessment | 82.0 Unit on scale | Standard Deviation 16.8 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment | Satisfaction dimension score: Baseline | 61.0 Unit on scale | Standard Deviation 13.3 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment | Satisfaction dimension score: Last assessment | 64.4 Unit on scale | Standard Deviation 14.7 |
Comparison: Convenience dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: <0.0001Paired t-test
Comparison: Satisfaction dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.0004Paired t-test
Primary
Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups
Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.
Time frame: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups | Convenience dimension score | 80.4 Unit on scale | Standard Deviation 13.6 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups | Satisfaction dimension score | 63.9 Unit on scale | Standard Deviation 11.6 |
| Cohort B (New Patients - VKA) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups | Convenience dimension score | 76.0 Unit on scale | Standard Deviation 18.9 |
| Cohort B (New Patients - VKA) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups | Satisfaction dimension score | 60.9 Unit on scale | Standard Deviation 12.8 |
Comparison: Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.0287Paired t-test
Comparison: Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.03Paired t-test
Primary
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups
Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.
Time frame: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups | Convenience dimension score | 78.4 Unit on scale | Standard Deviation 14.6 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups | Satisfaction dimension score | 61.5 Unit on scale | Standard Deviation 12.7 |
| Cohort B (New Patients - VKA) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups | Convenience dimension score | 75.1 Unit on scale | Standard Deviation 19.6 |
| Cohort B (New Patients - VKA) | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups | Satisfaction dimension score | 59.9 Unit on scale | Standard Deviation 13.5 |
Comparison: Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.0423Paired t-test
Comparison: Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.2226Paired t-test
Primary
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment
Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.
Time frame: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment | Convenience dimension score: Baseline | 71.4 Unit on scale | Standard Deviation 21.8 |
| Cohort A (Switch Patients - Pradaxa) | Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment | Convenience dimension score: Second assessment | 79.6 Unit on scale | Standard Deviation 18.1 |
| Cohort A (Switch Patients - Pradaxa) | Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment | Satisfaction dimension score: Baseline | 61.0 Unit on scale | Standard Deviation 13.3 |
| Cohort A (Switch Patients - Pradaxa) | Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment | Satisfaction dimension score: Second assessment | 63.2 Unit on scale | Standard Deviation 14.6 |
Comparison: Convenience dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: <0.0001Paired t-test
Comparison: Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.0174Paired t-test
Primary
Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A
Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)
Time frame: Baseline (Visit1)
Population: Eligible patients who took the prescribed treatment and without an important protocol violation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A | 4.28 Years | Standard Deviation 3.63 |
Primary
Patient Characterization at Baseline - Categorical Parameters
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Time frame: Baseline (Visit1)
Population: Eligible patients who took the prescribed treatment and without an important protocol violation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:Antithrombotic agents | 15.3 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | MH: Bleedings | 2.6 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | >= 75 Years | 34.3 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | MH: Other Conditions | 5.8 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | DoP:150 mg twice daily | 31.9 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:Lipid modifying agents | 46.7 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Thromboembolism | 9.8 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:NSAIDS | 1.8 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:Antihypertensives | 67.5 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Cardiovascular Conditions | 64.1 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Other Conditions | 26.9 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Bleedings | 2.4 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | Female | 34.3 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | DoP:110 mg twice daily | 68.1 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:H2-receptor antagonists | 8.7 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | Male | 65.7 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | >= 65 and < 75 Years | 40.6 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:Amiodarone | 7.4 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | MH: Thromboembolism | 6.3 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | < 65 Years | 25.1 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:Proton pump inhibitors | 16.4 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | MH: Cardiovascular Conditions | 7.7 Percentage of participant |
| Cohort A (Switch Patients - Pradaxa) | Patient Characterization at Baseline - Categorical Parameters | CM:Verapamil | 1.1 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Cardiovascular Conditions | 50.9 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Amiodarone | 7.1 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | < 65 Years | 33.2 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | >= 65 and < 75 Years | 43.3 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | >= 75 Years | 23.5 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | Female | 38.6 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | Male | 61.4 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Thromboembolism | 3.4 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Cardiovascular Conditions | 5.1 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Bleedings | 1.0 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Other Conditions | 3.7 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Thromboembolism | 4.7 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Bleedings | 2.5 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Other Conditions | 20.8 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Antihypertensives | 56.0 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Lipid modifying agents | 33.5 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Antithrombotic agents | 9.5 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Proton pump inhibitors | 13.9 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:H2-receptor antagonists | 7.1 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:NSAIDS | 2.9 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Verapamil | 1.5 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | DoP:110 mg twice daily | 58.0 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | DoP:150 mg twice daily | 42.0 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Lipid modifying agents | 28.0 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Cardiovascular Conditions | 4.4 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:NSAIDS | 1.7 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Antithrombotic agents | 19.8 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Thromboembolism | 1.5 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | >= 65 and < 75 Years | 29.4 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Proton pump inhibitors | 7.9 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | Male | 69.1 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Amiodarone | 5.8 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | Female | 30.9 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Cardiovascular Conditions | 40.5 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | < 65 Years | 53.6 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Bleedings | 2.3 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Bleedings | 0.9 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:H2-receptor antagonists | 2.0 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Other Conditions | 17.8 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CoMo: Thromboembolism | 7.6 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | >= 75 Years | 16.9 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Antihypertensives | 47.8 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | MH: Other Conditions | 3.8 Percentage of participant |
| Cohort B (New Patients - VKA) | Patient Characterization at Baseline - Categorical Parameters | CM:Verapamil | 1.7 Percentage of participant |
Secondary
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B
For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively. The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation. The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).
Time frame: Baseline (Visit1)
Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. PACT-Q1 data which were collected after the first dose or using incorrect procedure were excluded from the summary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A3 - Expectations of side effects | 2.5 Unit on scale | Standard Deviation 1 |
| Cohort A (Switch Patients - Pradaxa) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A1 - Confidence in prevention of blood clots | 3.4 Unit on scale | Standard Deviation 1 |
| Cohort A (Switch Patients - Pradaxa) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A2 - Expectations of symptom relief | 3.4 Unit on scale | Standard Deviation 0.9 |
| Cohort A (Switch Patients - Pradaxa) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A4 - Importance of ease of use | 3.7 Unit on scale | Standard Deviation 0.9 |
| Cohort A (Switch Patients - Pradaxa) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A5 - Worries about making mistakes | 2.5 Unit on scale | Standard Deviation 1.2 |
| Cohort A (Switch Patients - Pradaxa) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A6 - Importance of independency | 3.7 Unit on scale | Standard Deviation 0.9 |
| Cohort A (Switch Patients - Pradaxa) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A7 - Worries about cost | 2.7 Unit on scale | Standard Deviation 1.2 |
| Cohort B (New Patients - VKA) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A7 - Worries about cost | 2.6 Unit on scale | Standard Deviation 1.2 |
| Cohort B (New Patients - VKA) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A3 - Expectations of side effects | 2.6 Unit on scale | Standard Deviation 1 |
| Cohort B (New Patients - VKA) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A5 - Worries about making mistakes | 2.5 Unit on scale | Standard Deviation 1.2 |
| Cohort B (New Patients - VKA) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A4 - Importance of ease of use | 3.5 Unit on scale | Standard Deviation 1 |
| Cohort B (New Patients - VKA) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A1 - Confidence in prevention of blood clots | 3.3 Unit on scale | Standard Deviation 1 |
| Cohort B (New Patients - VKA) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A6 - Importance of independency | 3.7 Unit on scale | Standard Deviation 1 |
| Cohort B (New Patients - VKA) | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | A2 - Expectations of symptom relief | 3.3 Unit on scale | Standard Deviation 1 |
Secondary
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 score.
Time frame: Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Convenience dimension score (Visit 2) | 79.6 Unit on scale | Standard Deviation 18.1 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Convenience dimension score (Visit 3) | 82.0 Unit on scale | Standard Deviation 16.8 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Satisfaction dimension score (Visit 2) | 63.2 Unit on scale | Standard Deviation 14.6 |
| Cohort A (Switch Patients - Pradaxa) | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Satisfaction dimension score (Visit 3) | 64.4 Unit on scale | Standard Deviation 14.7 |
Comparison: Convenience dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.1234Paired t-test
Comparison: Satisfaction dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.p-value: 0.974Paired t-test
Secondary
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score
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.
Time frame: Baseline (Visit1)
Population: Eligible patients who took the prescribed treatment and without an important protocol violation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score | 3.1 unit on scale | Standard Deviation 1.4 |
| Cohort B (New Patients - VKA) | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score | 2.6 unit on scale | Standard Deviation 1.4 |
| Cohort B (New Patients - VKA) | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score | 2.0 unit on scale | Standard Deviation 1.6 |
Secondary
Patient Characteristics at Baseline - Creatinine Clearance
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Time frame: Baseline (Visit1)
Population: Eligible patients who took the prescribed treatment and without an important protocol violation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Patient Characteristics at Baseline - Creatinine Clearance | 68.114 mL/min | Standard Deviation 23.147 |
| Cohort B (New Patients - VKA) | Patient Characteristics at Baseline - Creatinine Clearance | 75.367 mL/min | Standard Deviation 29.028 |
| Cohort B (New Patients - VKA) | Patient Characteristics at Baseline - Creatinine Clearance | 73.017 mL/min | Standard Deviation 29.179 |
Secondary
Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
Time frame: Baseline (Visit1)
Population: Eligible patients who took the prescribed treatment and without an important protocol violation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A (Switch Patients - Pradaxa) | Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score | 1.8 unit on scale | Standard Deviation 1.1 |
| Cohort B (New Patients - VKA) | Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score | 1.3 unit on scale | Standard Deviation 0.9 |
| Cohort B (New Patients - VKA) | Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score | 1.1 unit on scale | Standard Deviation 1.1 |