Atrial Fibrillation, Stroke
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 milligrams or 150 milligrams 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 |
|---|---|---|
| Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable) | Baseline | This endpoint is not assessable as the necessary data was not collected in the database |
| Characterization of Patients With Respect to Dosing of Pradaxa | Baseline and up to 210 days | The data presented in this outcome measure is percentage of patients in both cohorts receiving 110 mg and 150 mg dose of Pradaxa at baseline (V1). |
| Duration in Months of Previous VKA Treatment | Baseline | The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A. |
| Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment | From baseline up to 210 days | The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences. |
| Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment | From baseline up to 210 days | The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences. |
| Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | Day 30 up to Day 210 | The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences. |
| Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | Day 30 up to Day 210 | The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences. |
| Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | Baseline | CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. Score of \< 2 was considered as low or intermediate risk and score of ≥ 2 was considered as high risk. |
| Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | Baseline | HAS-BLED is a scoring system developed to assess 1-year risk of major bleeding in patients with atrial fibrillation. A calculated HAS-BLED score is between 0 and 9 and based on eight parameters with a weighted value of 0-2. A high score corresponds to a greater risk, while low score corresponds to a lower risk. Data presented are percentage of patients with high and low risk. |
| Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | Baseline and up to 210 days | Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Creatinine is filtered from the blood by the kidneys and released into the urine. A creatinine clearance test measures creatinine levels in both a sample of blood and a sample of urine from a 24-hour urine collection. The results are used to calculate the amount of creatinine that has been cleared from the blood and passed into the urine. Data presented here are geometric mean and confidence interval of creatinine clearance for patients at baseline (V1), initiation stage (V2) and continuation stage (V3). |
| Characterization of Patients With Respect to Comorbidities | Baseline | Comorbidity is the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. Data presented here are percentage of total patients with comorbidities. |
| Characterization of Patients With Respect to Concomitant Therapies | Baseline | Concomitant therapies are two or more drugs used or given at or almost at the same time. The data presented here are percentage of total patients for taking concomitant medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of PACT-Q1 Items at Baseline | Baseline | Patients in Cohort B were given PACT-Q1 to assess patients' expectation from Anticoagulation therapy. Following are the seven items from PACT-Q1. The score range is 1-5. Each question is analyzed individually, with higher score indicating better outcome. A1 - How confident are you that your anticoagulant treatment (AT) will prevent blood clots? A2 - Do you expect that your AT will relieve some of the symptoms you experience? A3 - Do you expect that your AT will cause side effects such as minor bruises or bleeding? A4 - How important is it for you to have an AT that is easy to take? A5 - How concerned are you about making mistakes when taking your AT? A6 - How important is it for you to take care of your AT by yourself? A7 - How concerned are you about how much you may have to pay for your AT? For questions A1, A2, A4 and A6, higher score is higher expectations of the treatment and for questions A3, A5 and A7, lower score is higher expectations of the treatment. |
| PACT-Q2 Scores at Last Assessment Compared to Second Assessment | From 30 days up to 210 days | The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. Due to the non-normality of the data, results presented here are median change in PACT-Q2 scores between initiation stage (V2) and Continuation stage (V3). |
Countries
Austria, Bulgaria, Czechia, Estonia, Hungary, Israel, Latvia, Poland, Romania, Russia, Serbia, Slovenia
Participant flow
Recruitment details
This is an observational study. Total 9472 patients with Non-Valvular Atrial Fibrillation (NVAF) were enrolled in the study using Vitamin K antagonist (VKA) therapy prior to being switched to Pradaxa® and newly diagnosed with NVAF and initiated Pradaxa® or VKA. Patients were followed up for observational period of approximately 6 months.
Pre-assignment details
All patients were screened for eligibility. All enrolled patients met all implemented inclusion/exclusion criteria. Out of 9472 enrolled patients, 7 patients with unknown study treatment were not included in the main analysis set. Total 9465 patients were included in the main analysis set and started the study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Patients with Non-Valvular Atrial Fibrillation (NVAF) using Vitamin K Antagonist (VKA) therapy prior to being switched to oral dose of Pradaxa® 110 milligram (mg) and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) were included. | 4,100 |
| Cohort B- Pradaxa® Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Pradaxa® 110 mg and Pradaxa® 150 mg hard capsules twice daily containing Dabigatran etexilate (active ingredient: Dabigatran) therapy. | 3,179 |
| Cohort B- VKA Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included. | 2,186 |
| Total | 9,465 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Other | 83 | 49 | 17 |
| Overall Study | Permanently discontinued the treatment | 157 | 161 | 110 |
Baseline characteristics
| Characteristic | Cohort A | Cohort B- Pradaxa® | Cohort B- VKA | Total |
|---|---|---|---|---|
| Age, Continuous | 70.5 Years STANDARD_DEVIATION 9.57 | 68.6 Years STANDARD_DEVIATION 10.1 | 68.5 Years STANDARD_DEVIATION 9.49 | 69.4 Years STANDARD_DEVIATION 9.79 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 1998 Participants | 1602 Participants | 1080 Participants | 4680 Participants |
| Sex: Female, Male Male | 2102 Participants | 1577 Participants | 1106 Participants | 4785 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 4,066 | 2 / 3,164 | 4 / 2,181 | 6 / 5,345 |
| other Total, other adverse events | 0 / 4,066 | 0 / 3,164 | 0 / 2,181 | 0 / 5,345 |
| serious Total, serious adverse events | 26 / 4,066 | 25 / 3,164 | 15 / 2,181 | 40 / 5,345 |
Outcome results
Primary
Characterization of Patients With Respect to Comorbidities
Comorbidity is the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. Data presented here are percentage of total patients with comorbidities.
Time frame: Baseline
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Characterization of Patients With Respect to Comorbidities | 86.4 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Comorbidities | 83.4 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Comorbidities | 90.9 Percentage of patients (%) |
Primary
Characterization of Patients With Respect to Concomitant Therapies
Concomitant therapies are two or more drugs used or given at or almost at the same time. The data presented here are percentage of total patients for taking concomitant medication.
Time frame: Baseline
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Characterization of Patients With Respect to Concomitant Therapies | 86.4 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Concomitant Therapies | 83.4 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Concomitant Therapies | 91.2 Percentage of patients (%) |
Primary
Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. Score of \< 2 was considered as low or intermediate risk and score of ≥ 2 was considered as high risk.
Time frame: Baseline
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | Low risk (Score < 2) | 5.4 Percentage of patients (%) |
| Cohort A | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | High risk (Score >= 2) | 88.3 Percentage of patients (%) |
| Cohort A | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | Data not available | 6.3 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | Low risk (Score < 2) | 8.2 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | High risk (Score >= 2) | 87.8 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | Data not available | 4.0 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | High risk (Score >= 2) | 91.4 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | Data not available | 1.6 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score | Low risk (Score < 2) | 7.0 Percentage of patients (%) |
Primary
Characterization of Patients With Respect to Dosing of Pradaxa
The data presented in this outcome measure is percentage of patients in both cohorts receiving 110 mg and 150 mg dose of Pradaxa at baseline (V1).
Time frame: Baseline and up to 210 days
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Characterization of Patients With Respect to Dosing of Pradaxa | Pradaxa 110 mg at V1 | 34.9 Percentage of patients (%) |
| Cohort A | Characterization of Patients With Respect to Dosing of Pradaxa | Pradaxa 150 mg at V1 | 65.1 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Dosing of Pradaxa | Pradaxa 110 mg at V1 | 30.4 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Dosing of Pradaxa | Pradaxa 150 mg at V1 | 69.6 Percentage of patients (%) |
Primary
Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
HAS-BLED is a scoring system developed to assess 1-year risk of major bleeding in patients with atrial fibrillation. A calculated HAS-BLED score is between 0 and 9 and based on eight parameters with a weighted value of 0-2. A high score corresponds to a greater risk, while low score corresponds to a lower risk. Data presented are percentage of patients with high and low risk.
Time frame: Baseline
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | High risk (Score >= 3) | 59.2 Percentage of patients (%) |
| Cohort A | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | Low risk (Score < 3) | 31.0 Percentage of patients (%) |
| Cohort A | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | Data not available | 9.7 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | Data not available | 6.8 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | Low risk (Score < 3) | 64.8 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | High risk (Score >= 3) | 29.1 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | Low risk (Score < 3) | 65.7 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | Data not available | 2.9 Percentage of patients (%) |
| Cohort B- VKA | Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score | High risk (Score >= 3) | 31.3 Percentage of patients (%) |
Primary
Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Creatinine is filtered from the blood by the kidneys and released into the urine. A creatinine clearance test measures creatinine levels in both a sample of blood and a sample of urine from a 24-hour urine collection. The results are used to calculate the amount of creatinine that has been cleared from the blood and passed into the urine. Data presented here are geometric mean and confidence interval of creatinine clearance for patients at baseline (V1), initiation stage (V2) and continuation stage (V3).
Time frame: Baseline and up to 210 days
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V2 | 74.59 millilitre per minute (mL/min) |
| Cohort A | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V1 | 73.89 millilitre per minute (mL/min) |
| Cohort A | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V3 | 72.82 millilitre per minute (mL/min) |
| Cohort B- VKA | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V2 | 75.27 millilitre per minute (mL/min) |
| Cohort B- VKA | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V1 | 76.24 millilitre per minute (mL/min) |
| Cohort B- VKA | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V3 | 74.24 millilitre per minute (mL/min) |
| Cohort B- VKA | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V1 | 71.83 millilitre per minute (mL/min) |
| Cohort B- VKA | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V3 | 71.79 millilitre per minute (mL/min) |
| Cohort B- VKA | Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) | V2 | 71.86 millilitre per minute (mL/min) |
Primary
Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Time frame: Day 30 up to Day 210
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A | Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V2 | 82.69 Unit on scale |
| Cohort A | Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V3 | 86.54 Unit on scale |
| Cohort B- VKA | Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V2 | 50.00 Unit on scale |
| Cohort B- VKA | Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V3 | 59.62 Unit on scale |
Comparison: Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)p-value: <0.001Mixed Models Analysis
Comparison: Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)p-value: <0.001Mixed Models Analysis
Primary
Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Time frame: From baseline up to 210 days
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A | Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment | Median change from V1 to V3 | 23.08 Unit on scale |
| Cohort A | Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment | Median change from V1 to V2 | 19.23 Unit on scale |
Comparison: Statistical analysis for median change in PACT-Q2 scores from V1 to V2p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Statistical analysis for median change in convenience PACT-Q2 scores from V1 to V3p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
Duration in Months of Previous VKA Treatment
The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.
Time frame: Baseline
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Duration in Months of Previous VKA Treatment | 34.00 Months | Standard Deviation 39.93 |
Primary
Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Time frame: Day 30 up to Day 210
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A | Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V2 | 67.86 Unit on scale |
| Cohort A | Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V3 | 71.43 Unit on scale |
| Cohort B- VKA | Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V2 | 50.00 Unit on scale |
| Cohort B- VKA | Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups | V3 | 50.00 Unit on scale |
Comparison: Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)p-value: <0.001Mixed Models Analysis
Comparison: Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)p-value: <0.001Mixed Models Analysis
Primary
Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
Time frame: From baseline up to 210 days
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A | Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment | Median change from V1 to V2 | 17.86 Unit on scale |
| Cohort A | Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment | Median change from V1 to V3 | 21.43 Unit on scale |
Comparison: Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V2p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V3p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable)
This endpoint is not assessable as the necessary data was not collected in the database
Time frame: Baseline
Population: Treated set (Necessary data was not collected in the data base)
Secondary
Description of PACT-Q1 Items at Baseline
Patients in Cohort B were given PACT-Q1 to assess patients' expectation from Anticoagulation therapy. Following are the seven items from PACT-Q1. The score range is 1-5. Each question is analyzed individually, with higher score indicating better outcome. A1 - How confident are you that your anticoagulant treatment (AT) will prevent blood clots? A2 - Do you expect that your AT will relieve some of the symptoms you experience? A3 - Do you expect that your AT will cause side effects such as minor bruises or bleeding? A4 - How important is it for you to have an AT that is easy to take? A5 - How concerned are you about making mistakes when taking your AT? A6 - How important is it for you to take care of your AT by yourself? A7 - How concerned are you about how much you may have to pay for your AT? For questions A1, A2, A4 and A6, higher score is higher expectations of the treatment and for questions A3, A5 and A7, lower score is higher expectations of the treatment.
Time frame: Baseline
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Description of PACT-Q1 Items at Baseline | A5- A lot | 27.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A7- A little | 14.8 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A1- Moderately | 27.8 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A7- Moderately | 31.0 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A5- Extremely | 8.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A7- A lot | 26.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A1- Missing | 2.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A7- Extremely | 14.4 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A6- Missing | 2.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A1- Extremely | 7.7 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A3- A little | 38.4 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A2- Not at all | 11.6 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A1- A lot | 50.8 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A2- A little | 18.5 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A1- Not at all | 2.0 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A2- Moderately | 28.9 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A6- Not at all | 3.7 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A2- A lot | 30.9 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A5- Not at all | 17.3 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A2- Extremely | 7.9 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A6- A little | 7.9 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A3- Missing | 2.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A3- A lot | 12.6 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A3- Not at all | 17.8 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A6- Moderately | 17.3 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A3- Moderately | 26.9 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A5- A little | 25.3 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A3- Extremely | 2.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A6- A lot | 52.6 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A4- Missing | 2.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A1- A little | 9.6 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A4- Not at all | 3.3 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A6- Extremely | 16.3 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A4- A little | 5.6 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A5- Moderately | 19.8 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A4- Moderately | 16.4 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A7- Missing | 2.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A4- A lot | 56.1 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A2- Missing | 2.2 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A4- Extremely | 16.5 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A7- Not at all | 11.4 Percentage of patients (%) |
| Cohort A | Description of PACT-Q1 Items at Baseline | A5- Missing | 2.2 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A2- Missing | 2.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A3- Moderately | 30.7 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A1- A lot | 43.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A1- Missing | 2.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A1- Not at all | 3.1 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A1- A little | 13.0 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A1- Moderately | 31.9 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A5- Missing | 2.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A5- Not at all | 11.3 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A5- A little | 23.0 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A5- Moderately | 27.6 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A5- A lot | 27.5 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A5- Extremely | 8.3 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A3- A little | 38.9 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A6- Missing | 2.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A6- Not at all | 3.2 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A6- A little | 7.8 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A6- Moderately | 24.9 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A6- A lot | 49.8 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A6- Extremely | 11.9 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A7- Missing | 2.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A7- Not at all | 8.8 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A7- A little | 11.1 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A7- Moderately | 20.9 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A7- A lot | 36.9 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A7- Extremely | 20.0 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A1- Extremely | 6.1 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A2- Not at all | 11.8 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A2- A little | 23.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A2- Moderately | 31.2 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A2- A lot | 26.6 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A2- Extremely | 4.6 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A3- Missing | 2.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A3- Not at all | 13.2 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A3- A lot | 12.0 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A3- Extremely | 2.6 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A4- Missing | 2.4 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A4- Not at all | 2.7 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A4- A little | 7.3 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A4- Moderately | 20.5 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A4- A lot | 53.0 Percentage of patients (%) |
| Cohort B- VKA | Description of PACT-Q1 Items at Baseline | A4- Extremely | 14.1 Percentage of patients (%) |
Secondary
PACT-Q2 Scores at Last Assessment Compared to Second Assessment
The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. Due to the non-normality of the data, results presented here are median change in PACT-Q2 scores between initiation stage (V2) and Continuation stage (V3).
Time frame: From 30 days up to 210 days
Population: Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A | PACT-Q2 Scores at Last Assessment Compared to Second Assessment | Convenience PACT-Q2 | 1.92 Unit on scale |
| Cohort A | PACT-Q2 Scores at Last Assessment Compared to Second Assessment | Satisfaction PACT-Q2 | 3.57 Unit on scale |
Comparison: Median convenience and satisfaction PACT-Q2 scores at last assessment compared to second assessmentp-value: <0.001Wilcoxon (Mann-Whitney)