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).
Study Type
OBSERVATIONAL
Enrollment
9,472
Unnamed facility
Multiple Locations, Austria
Unnamed facility
Multiple Locations, Bulgaria
Unnamed facility
Multiple Locations, Czechia
Unnamed facility
Multiple Locations, Estonia
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
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
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.
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Unnamed facility
Multiple Locations, Hungary
Unnamed facility
Multiple Locations, Israel
Unnamed facility
Multiple Locations, Latvia
Unnamed facility
Multiple Locations, Poland
Unnamed facility
Multiple Locations, Romania
Unnamed facility
Multiple Locations, Russia
...and 2 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: Baseline
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
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