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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - VKA to Pradaxa switcher | Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa. | ||
| Cohort B - newly assigned to treatment | Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline up to 210 days |
| 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. | From baseline up to 210 days |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion criteria:
Cohort A:
OR
Cohort B:
Exclusion criteria:
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European patients with non valvular atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33929686 | Derived | Vinereanu D, Napalkov D, Bergler-Klein J, Benczur B, Ciernik M, Gotcheva N, Medvedchikov A, Poder P, Simic D, Skride A, Tang W, Trusz-Gluza M, Vesely J. Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study. J Thromb Thrombolysis. 2021 Nov;52(4):1195-1206. doi: 10.1007/s11239-021-02450-2. Epub 2021 Apr 30. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Cohort B- VKA | Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion crteria with known assigned treatment information.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Median | Full Range | Unit on scale | From baseline up to 210 days |
|
From first drug administration, until end of the study, up to 210 days.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. The safety analysis set including all the patients with actual follow up were used for this analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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Improper dose reduction in patients not fulfilling reduction criteria, Selection bias, Missing data, Creatinine clearance in minimals, Antiarrhythmic medication contraindicated to Pradaxa, Unassessable Stroke/bleeding related risk factors endpoint
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2017 | May 30, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 23, 2015 | May 30, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Day 30 up to Day 210 |
| 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. | Day 30 up to Day 210 |
| 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. | Baseline |
| 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. | Baseline |
| 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). | Baseline and up to 210 days |
| 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. | Baseline |
| 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. | Baseline |
| 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). | Baseline and up to 210 days |
| 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. | Baseline |
| 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 | Baseline |
| From 30 days up to 210 days |
| 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. | Baseline |
| Multiple Locations |
| Bulgaria |
| Multiple Locations | Czechia |
| Multiple Locations | Estonia |
| Multiple Locations | Hungary |
| Multiple Locations | Israel |
| Multiple Locations | Latvia |
| Multiple Locations | Poland |
| Multiple Locations | Romania |
| Multiple Locations | Russia |
| Multiple Locations | Serbia |
| Multiple Locations | Slovenia |
| 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. |
| BG002 | Cohort B- VKA | Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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. |
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Median | Full Range | Unit on scale | From baseline up to 210 days |
|
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Median | Full Range | Unit on scale | Day 30 up to Day 210 |
|
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Median | Full Range | Unit on scale | Day 30 up to Day 210 |
|
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Number | Percentage of patients (%) | Baseline |
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Number | Percentage of patients (%) | Baseline |
|
|
|
| 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). | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Geometric Mean | 95% Confidence Interval | millilitre per minute (mL/min) | Baseline and up to 210 days |
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Number | Percentage of patients (%) | Baseline |
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Number | Percentage of patients (%) | Baseline |
|
|
|
| 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). | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Number | Percentage of patients (%) | Baseline and up to 210 days |
|
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Mean | Standard Deviation | Months | Baseline |
|
|
|
| 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). | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information. | Posted | Median | Full Range | Unit on scale | From 30 days up to 210 days |
|
|
|
|
| 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 | Treated set (Necessary data was not collected in the data base) | Posted | Baseline |
|
|
| 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. | Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information | Posted | Number | Percentage of patients (%) | Baseline |
|
|
|
| 5 |
| 4,066 |
| 26 |
| 4,066 |
| 0 |
| 4,066 |
| EG001 | 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. | 2 | 3,164 | 25 | 3,164 | 0 | 3,164 |
| EG002 | Cohort B- VKA | Newly diagnosed patients with Non-Valvular Atrial Fibrillation (NVAF) and initiated Vitamin K Antagonist (VKA) therapy were included. | 4 | 2,181 | 15 | 2,181 | 0 | 2,181 |
| EG003 | Cohort B | 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) or Vitamin K Antagonist (VKA) therapy were included. | 6 | 5,345 | 40 | 5,345 | 0 | 5,345 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Appendiceal abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Calculus bladder | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
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| Cardioversion | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
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| Left atrial appendage occlusion | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
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| Meningioma surgery | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
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| Transurethral prostatectomy | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
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| Vascular stent insertion | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| Male |
|
|
| Wilcoxon (Mann-Whitney) |
Wilcoxon signed rank test has been used for this analysis |
| < 0.0001 |
| Other |
| V3 |
|
|
|
Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3) |
| Mixed Models Analysis |
| < 0.001 |
| Mean Difference (Net) |
| 23.341 |
| Standard Error of the Mean |
| 0.509 |
The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable. |
| Other |
| V3 |
|
|
|
Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3) |
| Mixed Models Analysis |
| < 0.001 |
| Mean Difference (Net) |
| 19.011 |
| Standard Error of the Mean |
| 0.408 |
The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable. |
| Other |
|
| Data not available |
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| Data not available |
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| V2 |
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| V3 |
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| A1- A little |
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| A1- Moderately |
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| A1- A lot |
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| A1- Extremely |
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| A2- Missing |
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| A2- Not at all |
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| A2- A little |
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| A2- Moderately |
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| A2- A lot |
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| A2- Extremely |
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| A3- Missing |
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| A3- Not at all |
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| A3- A little |
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| A3- Moderately |
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| A3- A lot |
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| A3- Extremely |
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| A4- Missing |
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| A4- Not at all |
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| A4- A little |
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| A4- Moderately |
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| A4- A lot |
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| A4- Extremely |
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| A5- Missing |
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| A5- Not at all |
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| A5- A little |
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| A5- Moderately |
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| A5- A lot |
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| A5- Extremely |
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| A6- Missing |
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| A6- Not at all |
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| A6- A little |
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| A6- Moderately |
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| A6- A lot |
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| A6- Extremely |
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| A7- Missing |
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| A7- Not at all |
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| A7- A little |
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| A7- Moderately |
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| A7- A lot |
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| A7- Extremely |
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