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
None listed
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 - Vitamin K Antagonist Treatment Duration | Baseline | Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics. |
| Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | Baseline | 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. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics. |
| Patient Characterization at Baseline - Creatinine Clearance | Baseline | Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics. |
| 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 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA). | The PACT-Q is 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 is 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 are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are 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 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA). | The PACT-Q2 is 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 are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison. |
| Patient Characterization at Baseline - Categorical Parameters | Baseline | Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Baseline | The PACT-Q1 is 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 are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: 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). |
| Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA). | The PACT-Q2 is 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 are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). |
Countries
Belgium, Denmark, Greece, Netherlands, Norway, Portugal, Sweden
Participant flow
Recruitment details
Non-interventional study (NIS) on patients diagnosed with non-valvular atrial fibrillation (NVAF).
Pre-assignment details
A total of 1852 patients were enrolled, out of which 1822 were found eligible.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Pradaxa® Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (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) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran). | 585 |
| Cohort B Pradaxa® Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran). | 1,159 |
| Cohort B VKA Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician. | 78 |
| Total | 1,822 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 9 | 0 |
| Overall Study | Other | 1 | 0 | 0 |
| Overall Study | Other adverse event | 20 | 30 | 0 |
| Overall Study | Other than specified | 10 | 31 | 5 |
| Overall Study | Refuse to continue in the study | 3 | 13 | 1 |
| Overall Study | Worsening of other pre-existing disease | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort A Pradaxa® | Cohort B Pradaxa® | Cohort B VKA | Total |
|---|---|---|---|---|
| Age, Continuous | 73.3 Years STANDARD_DEVIATION 8.9 | 72.7 Years STANDARD_DEVIATION 9.1 | 74.9 Years STANDARD_DEVIATION 10.1 | 73.0 Years STANDARD_DEVIATION 9.1 |
| Age, Customized ≥ 65 and < 75 years | 213 Participants | 424 Participants | 22 Participants | 659 Participants |
| Age, Customized < 65 years | 83 Participants | 207 Participants | 10 Participants | 300 Participants |
| Age, Customized ≥ 75 years | 289 Participants | 528 Participants | 46 Participants | 863 Participants |
| CHA2DS2-VASc stroke risk score at baseline High risk (score >=2) | 537 Participants | 1033 Participants | 75 Participants | 1645 Participants |
| CHA2DS2-VASc stroke risk score at baseline Intermediate risk (score = 1) | 48 Participants | 126 Participants | 3 Participants | 177 Participants |
| Creatinine clearance at baseline <30 milliliter per minute (mL/min) | 0 Participants | 0 Participants | 7 Participants | 7 Participants |
| Creatinine clearance at baseline 30 to < 50 mL/min | 85 Participants | 150 Participants | 23 Participants | 258 Participants |
| Creatinine clearance at baseline 50 to < 80 mL/min | 277 Participants | 510 Participants | 25 Participants | 812 Participants |
| Creatinine clearance at baseline ≥ 80 mL/min | 168 Participants | 371 Participants | 17 Participants | 556 Participants |
| Creatinine clearance at baseline Missing | 55 Participants | 128 Participants | 6 Participants | 189 Participants |
| HAS-BLED bleeding risk score at baseline High risk (score >=3) | 197 Participants | 128 Participants | 19 Participants | 344 Participants |
| HAS-BLED bleeding risk score at baseline Low risk (score < 3) | 388 Participants | 1031 Participants | 59 Participants | 1478 Participants |
| Owner of medical practice Community health center | 24 Participants | 56 Participants | 12 Participants | 92 Participants |
| Owner of medical practice Health Maintenance Organisation | 7 Participants | 6 Participants | 0 Participants | 13 Participants |
| Owner of medical practice Medical / academic health center | 86 Participants | 143 Participants | 13 Participants | 242 Participants |
| Owner of medical practice Missing | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Owner of medical practice Other | 11 Participants | 22 Participants | 0 Participants | 33 Participants |
| Owner of medical practice Other health care corporation | 16 Participants | 8 Participants | 3 Participants | 27 Participants |
| Owner of medical practice Other hospital | 51 Participants | 140 Participants | 10 Participants | 201 Participants |
| Owner of medical practice Physician or physician group | 390 Participants | 783 Participants | 39 Participants | 1212 Participants |
| Race/Ethnicity, Customized | NA Participants | NA Participants | NA Participants | NA Participants |
| Region of Enrollment Northern Europe | 252 Participants | 447 Participants | 39 Participants | 738 Participants |
| Region of Enrollment Southern Europe | 333 Participants | 712 Participants | 39 Participants | 1084 Participants |
| Sex: Female, Male Female | 258 Participants | 520 Participants | 43 Participants | 821 Participants |
| Sex: Female, Male Male | 327 Participants | 639 Participants | 35 Participants | 1001 Participants |
| Speciality of treating physician Cardiologist | 548 Participants | 1087 Participants | 67 Participants | 1702 Participants |
| Speciality of treating physician General practitioner | 23 Participants | 7 Participants | 2 Participants | 32 Participants |
| Speciality of treating physician Missing | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Speciality of treating physician Other specialist | 14 Participants | 64 Participants | 8 Participants | 86 Participants |
| Type of hospital or practise Missing | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Type of hospital or practise Other | 5 Participants | 18 Participants | 0 Participants | 23 Participants |
| Type of hospital or practise Private | 373 Participants | 753 Participants | 44 Participants | 1170 Participants |
| Type of hospital or practise Public | 207 Participants | 387 Participants | 33 Participants | 627 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 585 | 5 / 1,159 | 1 / 78 |
| other Total, other adverse events | 0 / 585 | 0 / 1,159 | 0 / 78 |
| serious Total, serious adverse events | 4 / 585 | 8 / 1,159 | 2 / 78 |
Outcome results
Primary
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
The PACT-Q2 is 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 are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.
Time frame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Population: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | CDS-Visit 2 | 78.3 Units on Scale | Standard Deviation 13.4 |
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | CDS-Visit 3 | 80.3 Units on Scale | Standard Deviation 10.5 |
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | SDS-Visit 2 | 65.9 Units on Scale | Standard Deviation 7.8 |
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | SDS-Visit 3 | 68.4 Units on Scale | Standard Deviation 8.8 |
| Cohort B VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | SDS-Visit 3 | 58.8 Units on Scale | Standard Deviation 15.9 |
| Cohort B VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | CDS-Visit 2 | 69.1 Units on Scale | Standard Deviation 22.6 |
| Cohort B VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | SDS-Visit 2 | 58.0 Units on Scale | Standard Deviation 13.3 |
| Cohort B VKA | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | CDS-Visit 3 | 69.5 Units on Scale | Standard Deviation 22.3 |
Comparison: Between group comparison of Visit 3 SDSp-value: 0.0004Propensity score matching method
Comparison: Between group comparison of Visit 2 CDSp-value: 0.0005Propensity score matching method
Comparison: Between group comparison of Visit 3 CDSp-value: 0.0002Propensity score matching method
Comparison: Between group comparison of Visit 2 SDSp-value: 0.0002Propensity score matching method
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 is 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 is 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 are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Time frame: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Population: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A Pradaxa® | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | CDS-Baseline | 63.4 Units on Scale | Standard Deviation 25.2 |
| Cohort A Pradaxa® | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | CDS-Visit 2 | 77.3 Units on Scale | Standard Deviation 19.4 |
| Cohort A Pradaxa® | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | CDS-Visit 3 | 79.2 Units on Scale | Standard Deviation 17.9 |
| Cohort A Pradaxa® | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | SDS-Baseline | 53.8 Units on Scale | Standard Deviation 16.8 |
| Cohort A Pradaxa® | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | SDS-Visit 2 | 67.7 Units on Scale | Standard Deviation 13.9 |
| Cohort A Pradaxa® | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | SDS-Visit 3 | 70.0 Units on Scale | Standard Deviation 13 |
Comparison: Within group comparison of Baseline CDS with that of Visit 2.p-value: <0.0001Paired t-test
Comparison: Within group comparison of Baseline CDS with that of Visit 3.p-value: <0.0001Paired t-test
Comparison: Within group comparison of Baseline SDS with that of Visit 2.p-value: <0.0001Paired t-test
Comparison: Within group comparison of Baseline SDS with that of Visit 3.p-value: <0.0001Paired t-test
Primary
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding 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. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.
Time frame: Baseline
Population: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A Pradaxa® | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | CHA2DS2-VASc | 3.4 Units on scale | Standard Deviation 1.5 |
| Cohort A Pradaxa® | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | HAS-BLED | 2.1 Units on scale | Standard Deviation 0.9 |
| Cohort B VKA | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | CHA2DS2-VASc | 3.2 Units on scale | Standard Deviation 1.4 |
| Cohort B VKA | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | HAS-BLED | 1.7 Units on scale | Standard Deviation 0.8 |
| Cohort B VKA | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | CHA2DS2-VASc | 3.8 Units on scale | Standard Deviation 1.3 |
| Cohort B VKA | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | HAS-BLED | 2.0 Units on scale | Standard Deviation 1 |
Primary
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.
Time frame: Baseline
Population: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A Pradaxa® | Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration | 4.44 Years | Standard Deviation 3.65 |
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 and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Time frame: Baseline
Population: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | MH: Other Conditions | 8.2 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: NSAIDS | 0.5 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Proton pump inhibitors | 18.8 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CoMo: Thromboembolism | 5.8 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | Gender: Male | 55.9 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Antiarrhythmic agents | 29.4 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CoMo: Cardiovascular Conditions | 79.7 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | Age: ≥ 65 and < 75 years | 36.4 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Lipid modifying agents | 45.3 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CoMo: Bleedings | 3.6 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Antihypertensives | 84.8 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: H2-receptor antagonists | 2.1 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CoMo: Other Conditions | 21.9 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | Gender: Female | 44.1 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | Age: < 65 years | 14.2 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Verapamil | 3.6 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | MH: Thromboembolism | 14.0 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | DoP: 110 mg twice daily | 55.9 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Antidepressants | 4.4 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | MH: Cardiovascular Conditions | 22.4 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | Age: ≥ 75 years | 49.4 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Amiodarone | 3.9 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | MH: Bleedings | 4.1 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | DoP: 150 mg twice daily | 44.1 Percentage of participants |
| Cohort A Pradaxa® | Patient Characterization at Baseline - Categorical Parameters | CM: Antithrombotic agents | 7.4 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | DoP: 150 mg twice daily | 42.7 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Age: < 65 years | 17.9 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Age: ≥ 65 and < 75 years | 36.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Age: ≥ 75 years | 45.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Gender: Male | 55.1 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Gender: Female | 44.9 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Thromboembolism | 9.1 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Cardiovascular Conditions | 18.5 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Bleedings | 2.5 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Other Conditions | 6.4 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Thromboembolism | 4.0 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Cardiovascular Conditions | 79.4 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Bleedings | 2.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Other Conditions | 18.4 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antihypertensives | 81.1 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Lipid modifying agents | 42.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antiarrhythmic agents | 25.4 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Proton pump inhibitors | 15.9 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antithrombotic agents | 10.1 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Amiodarone | 5.0 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antidepressants | 4.3 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Verapamil | 2.8 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: H2-receptor antagonists | 0.9 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: NSAIDS | 1.1 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | DoP: 110 mg twice daily | 57.3 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: H2-receptor antagonists | 0.0 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Proton pump inhibitors | 26.9 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Bleedings | 7.7 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Age: ≥ 75 years | 59.0 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antithrombotic agents | 21.8 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Cardiovascular Conditions | 21.8 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Age: < 65 years | 12.8 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Amiodarone | 2.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Thromboembolism | 12.8 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: NSAIDS | 2.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antidepressants | 6.4 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Bleedings | 7.7 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Gender: Female | 55.1 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Other Conditions | 25.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Lipid modifying agents | 51.3 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Age: ≥ 65 and < 75 years | 28.2 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antihypertensives | 84.6 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Cardiovascular Conditions | 82.1 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | Gender: Male | 44.9 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CoMo: Thromboembolism | 9.0 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Verapamil | 1.3 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | CM: Antiarrhythmic agents | 19.2 Percentage of participants |
| Cohort B VKA | Patient Characterization at Baseline - Categorical Parameters | MH: Other Conditions | 9.0 Percentage of participants |
Primary
Patient Characterization 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
Population: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A Pradaxa® | Patient Characterization at Baseline - Creatinine Clearance | 74.40 millilitre/ minute [mL/min] | Standard Deviation 27.08 |
| Cohort B VKA | Patient Characterization at Baseline - Creatinine Clearance | 75.89 millilitre/ minute [mL/min] | Standard Deviation 26.6 |
| Cohort B VKA | Patient Characterization at Baseline - Creatinine Clearance | 63.83 millilitre/ minute [mL/min] | Standard Deviation 37.55 |
Secondary
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
The PACT-Q1 is 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 are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: 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: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q1 score at Visit 1 obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A Pradaxa® | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A3 | 2.7 Units on scale | Standard Deviation 0.9 |
| Cohort A Pradaxa® | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A5 | 2.8 Units on scale | Standard Deviation 1.4 |
| Cohort A Pradaxa® | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A2 | 3.1 Units on scale | Standard Deviation 1.2 |
| Cohort A Pradaxa® | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A6 | 4.1 Units on scale | Standard Deviation 0.9 |
| Cohort A Pradaxa® | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A4 | 4.2 Units on scale | Standard Deviation 0.8 |
| Cohort A Pradaxa® | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A7 | 2.9 Units on scale | Standard Deviation 1.4 |
| Cohort A Pradaxa® | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A1 | 3.8 Units on scale | Standard Deviation 0.8 |
| Cohort B VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A7 | 2.8 Units on scale | Standard Deviation 1.5 |
| Cohort B VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A1 | 3.7 Units on scale | Standard Deviation 0.8 |
| Cohort B VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A2 | 2.8 Units on scale | Standard Deviation 1.2 |
| Cohort B VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A3 | 2.8 Units on scale | Standard Deviation 1 |
| Cohort B VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A4 | 3.8 Units on scale | Standard Deviation 1 |
| Cohort B VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A5 | 2.9 Units on scale | Standard Deviation 1.4 |
| Cohort B VKA | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | A6 | 3.9 Units on scale | Standard Deviation 1 |
Secondary
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
The PACT-Q2 is 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 are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Time frame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Population: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | CDS-Visit 2 | 77.3 Units on Scale | Standard Deviation 19.4 |
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | CDS-Visit 3 | 79.2 Units on Scale | Standard Deviation 17.9 |
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | SDS-Visit 2 | 67.7 Units on Scale | Standard Deviation 13.9 |
| Cohort A Pradaxa® | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | SDS-Visit 3 | 70.0 Units on Scale | Standard Deviation 13 |
Comparison: Within group comparison of Visit 2 CDS with that of Visit 3.p-value: <0.0001Paired t-test
Comparison: Within group comparison of Visit 2 SDS with that of Visit 3.p-value: <0.0001Paired t-test