Atrial Fibrillation
Conditions
Brief summary
The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.
Interventions
DRUGNOAC
New Oral Anticoagulant
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient is willing and provides written informed consent to participate in this study * The patient is at least 18 years of age * The patient has a diagnosis of non-valvular atrial fibrillation (NVAF) * The patient is on treatment with NOAC according to its approved local SmPC and has initiated his first NOAC starting from November 2016
Exclusion criteria
-if the current participating patient participate in any clinical trial of a drug or device will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | Start of the first NOAC treatment | Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation. |
| Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Start of the first NOAC treatment | Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. |
| Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Start of the first NOAC treatment | Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 1. Low risk (score 0 in male; score 1 in female) 2. Moderate risk (score 1 in male; score 2 in female) 3. High risk (score ≥2 in male; score ≥3 in female) |
| Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | Start of the first NOAC treatment | Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding. |
| Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Start of the first NOAC treatment | Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: 1. Low risk (score 0) 2. Moderate risk (score 1-2) 3. High risk (score ≥3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reason for Treatment Changes | Start of the first NOAC treatment | Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC. |
| Number of Patients With Previous Treatment With Vitamin K Antagonists | single visit (Day 1) | Number of patient with Previous Treatment with Vitamin K Antagonists. |
| Appropriateness of NOACs Prescription | single visit (Day 1) | Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown. |
| Patient's Knowledge About His Condition | single visit (Day 1) | At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed. Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment? |
| Duration of Previous VKA Treatment | Through the observational period with an average of 43.8 months, data collected during a single visit. | Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC |
| Mean Number of Visits to the Physician Per Year | 1 year (data collected during single visit on day 1) | Mean number of visits to the physician per year considered for the NOAC Management. |
| Duration of First NOAC, All NOAC and Subsequent NOAC Treatment | Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit. | Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC). |
| Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC | single visit (Day 1) | Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC |
| Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | single visit (Day 1) | Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC. |
Countries
Spain
Participant flow
Recruitment details
Patients with Non Valvular Atrial Fibrillation (NVAF) in Spain, mainly from the hospital setting were on treatment with New Oral Anticoagulant (NOAC) according to its approved local Summary of Product Characteristics (SmPC) and have initiated their first NOAC starting from November 2016 were included in this trial.
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites in Spain to ensure that subjects met all incl/excl criteria. 45 patients (out of 1008 enrolled), did not meet at least one of the selection criteria and were considered not eligible. Data analysis was carried out with 963 eligible patients.
Participants by arm
| Arm | Count |
|---|---|
| All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019. | 963 |
| Total | 963 |
Baseline characteristics
| Characteristic | All Patients | — |
|---|---|---|
| Age, Continuous | 73.6 Years STANDARD_DEVIATION 10.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 406 Participants | — |
| Sex: Female, Male Male | 557 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 314 |
| other Total, other adverse events | 0 / 314 |
| serious Total, serious adverse events | 3 / 314 |
Outcome results
Primary
Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 1. Low risk (score 0 in male; score 1 in female) 2. Moderate risk (score 1 in male; score 2 in female) 3. High risk (score ≥2 in male; score ≥3 in female)
Time frame: Start of the first NOAC treatment
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dabigatran | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Low risk | 3 Participants |
| Dabigatran | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | High risk | 252 Participants |
| Dabigatran | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Moderate risk | 53 Participants |
| Rivaroxaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Moderate risk | 34 Participants |
| Rivaroxaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Low risk | 10 Participants |
| Rivaroxaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | High risk | 207 Participants |
| Apixaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Moderate risk | 36 Participants |
| Apixaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Low risk | 3 Participants |
| Apixaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | High risk | 215 Participants |
| Edoxaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Low risk | 0 Participants |
| Edoxaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | High risk | 108 Participants |
| Edoxaban | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Moderate risk | 21 Participants |
| All Patients | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Moderate risk | 144 Participants |
| All Patients | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Low risk | 16 Participants |
| All Patients | Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | High risk | 782 Participants |
Primary
Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation
Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: 1. Low risk (score 0) 2. Moderate risk (score 1-2) 3. High risk (score ≥3)
Time frame: Start of the first NOAC treatment
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dabigatran | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Moderate risk | 219 Participants |
| Dabigatran | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Low risk | 17 Participants |
| Dabigatran | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | High risk | 72 Participants |
| Rivaroxaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Moderate risk | 157 Participants |
| Rivaroxaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Low risk | 29 Participants |
| Rivaroxaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | High risk | 65 Participants |
| Apixaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | High risk | 56 Participants |
| Apixaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Low risk | 27 Participants |
| Apixaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Moderate risk | 170 Participants |
| Edoxaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Moderate risk | 86 Participants |
| Edoxaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Low risk | 11 Participants |
| Edoxaban | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | High risk | 31 Participants |
| All Patients | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | High risk | 224 Participants |
| All Patients | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Moderate risk | 632 Participants |
| All Patients | Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Low risk | 84 Participants |
Primary
Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.
Time frame: Start of the first NOAC treatment
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dabigatran | Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | 72.8 Years | Standard Deviation 9.9 |
| Rivaroxaban | Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | 72.5 Years | Standard Deviation 10.7 |
| Apixaban | Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | 72.6 Years | Standard Deviation 9.8 |
| Edoxaban | Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | 74.0 Years | Standard Deviation 10 |
| All Patients | Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | 72.8 Years | Standard Deviation 10.1 |
Primary
Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Time frame: Start of the first NOAC treatment
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dabigatran | Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | 3.2 Unit on Scale | Standard Deviation 1.5 |
| Rivaroxaban | Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | 3.3 Unit on Scale | Standard Deviation 1.6 |
| Apixaban | Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | 3.3 Unit on Scale | Standard Deviation 1.5 |
| Edoxaban | Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | 3.3 Unit on Scale | Standard Deviation 1.5 |
| All Patients | Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | 3.3 Unit on Scale | Standard Deviation 1.5 |
Primary
Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation
Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.
Time frame: Start of the first NOAC treatment
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dabigatran | Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | 1.8 unit on scale | Standard Deviation 1 |
| Rivaroxaban | Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | 1.8 unit on scale | Standard Deviation 1.1 |
| Apixaban | Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | 1.7 unit on scale | Standard Deviation 1.1 |
| Edoxaban | Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | 1.8 unit on scale | Standard Deviation 1 |
| All Patients | Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | 1.8 unit on scale | Standard Deviation 1.1 |
Secondary
Appropriateness of NOACs Prescription
Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.
Time frame: single visit (Day 1)
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dabigatran | Appropriateness of NOACs Prescription | Reason 1 | 88 Participants |
| Dabigatran | Appropriateness of NOACs Prescription | Reason 2 | 10 Participants |
| Dabigatran | Appropriateness of NOACs Prescription | Reason 3 | 16 Participants |
| Dabigatran | Appropriateness of NOACs Prescription | Reason 4 | 16 Participants |
| Dabigatran | Appropriateness of NOACs Prescription | Reason 5 | 271 Participants |
| Dabigatran | Appropriateness of NOACs Prescription | Reason 6 | 102 Participants |
| Dabigatran | Appropriateness of NOACs Prescription | Reason 7 | 342 Participants |
| Dabigatran | Appropriateness of NOACs Prescription | Reason 8 | 118 Participants |
Secondary
Duration of First NOAC, All NOAC and Subsequent NOAC Treatment
Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).
Time frame: Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dabigatran | Duration of First NOAC, All NOAC and Subsequent NOAC Treatment | First NOAC | 9.4 Months | Standard Deviation 6.5 |
| Dabigatran | Duration of First NOAC, All NOAC and Subsequent NOAC Treatment | All NOAC | 9.6 Months | Standard Deviation 6.5 |
| Dabigatran | Duration of First NOAC, All NOAC and Subsequent NOAC Treatment | Subsequent NOAC | 5.1 Months | Standard Deviation 4.1 |
Secondary
Duration of Previous VKA Treatment
Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC
Time frame: Through the observational period with an average of 43.8 months, data collected during a single visit.
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed only for patients with previous VKA treatment (n=424). Dates of start and/or stop of previous VKA treatment were not available for 62 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dabigatran | Duration of Previous VKA Treatment | 46.6 Months | Standard Deviation 52.5 |
| Rivaroxaban | Duration of Previous VKA Treatment | 37.0 Months | Standard Deviation 50.6 |
| Apixaban | Duration of Previous VKA Treatment | 54.5 Months | Standard Deviation 58.9 |
| Edoxaban | Duration of Previous VKA Treatment | 34.0 Months | Standard Deviation 47.9 |
| All Patients | Duration of Previous VKA Treatment | 43.8 Months | Standard Deviation 53.2 |
Secondary
Mean Number of Visits to the Physician Per Year
Mean number of visits to the physician per year considered for the NOAC Management.
Time frame: 1 year (data collected during single visit on day 1)
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dabigatran | Mean Number of Visits to the Physician Per Year | 2.0 visits per year | Standard Deviation 1.1 |
Secondary
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose
Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.
Time frame: single visit (Day 1)
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who changed to a new NOAC. As per protocol this endpoint was to be analysed overall for all eligible patients who changed to a new NOAC. Thus, this endpoint was not analysed by NOAC type.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Dabigatran 110 mg | 5 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Dabigatran 150 mg | 4 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Rivaroxaban 10 mg | 1 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Rivaroxaban 15 mg | 2 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Rivaroxaban 20 mg | 4 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Apixaban 2.5 mg | 2 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Apixaban 5 mg | 8 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Edoxaban 30 mg | 2 Participants |
| Dabigatran | Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Edoxaban 60 mg | 4 Participants |
Secondary
Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC
Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC
Time frame: single visit (Day 1)
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dabigatran | Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC | Discontinue treatment | 4 Participants |
| Dabigatran | Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC | Dose adjustment | 20 Participants |
| Dabigatran | Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC | Change to a new NOAC | 32 Participants |
| Dabigatran | Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC | No change | 907 Participants |
Secondary
Number of Patients With Previous Treatment With Vitamin K Antagonists
Number of patient with Previous Treatment with Vitamin K Antagonists.
Time frame: single visit (Day 1)
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dabigatran | Number of Patients With Previous Treatment With Vitamin K Antagonists | Yes | 146 Participants |
| Dabigatran | Number of Patients With Previous Treatment With Vitamin K Antagonists | No | 168 Participants |
| Rivaroxaban | Number of Patients With Previous Treatment With Vitamin K Antagonists | Yes | 125 Participants |
| Rivaroxaban | Number of Patients With Previous Treatment With Vitamin K Antagonists | No | 128 Participants |
| Apixaban | Number of Patients With Previous Treatment With Vitamin K Antagonists | Yes | 100 Participants |
| Apixaban | Number of Patients With Previous Treatment With Vitamin K Antagonists | No | 166 Participants |
| Edoxaban | Number of Patients With Previous Treatment With Vitamin K Antagonists | No | 77 Participants |
| Edoxaban | Number of Patients With Previous Treatment With Vitamin K Antagonists | Yes | 53 Participants |
| All Patients | Number of Patients With Previous Treatment With Vitamin K Antagonists | Yes | 424 Participants |
| All Patients | Number of Patients With Previous Treatment With Vitamin K Antagonists | No | 539 Participants |
Secondary
Patient's Knowledge About His Condition
At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed. Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?
Time frame: single visit (Day 1)
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dabigatran | Patient's Knowledge About His Condition | Question 1. | Yes | 845 Participants |
| Dabigatran | Patient's Knowledge About His Condition | Question 1. | No | 118 Participants |
| Dabigatran | Patient's Knowledge About His Condition | Question 2. | Yes | 820 Participants |
| Dabigatran | Patient's Knowledge About His Condition | Question 2. | No | 143 Participants |
| Dabigatran | Patient's Knowledge About His Condition | Question 3. | Yes | 766 Participants |
| Dabigatran | Patient's Knowledge About His Condition | Question 3. | No | 197 Participants |
| Dabigatran | Patient's Knowledge About His Condition | Question 4. | Yes | 333 Participants |
| Dabigatran | Patient's Knowledge About His Condition | Question 4. | No | 630 Participants |
Secondary
Reason for Treatment Changes
Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.
Time frame: Start of the first NOAC treatment
Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who required treatment changes.As per protocol this endpoint was to be analysed overall for all eligible patients who required treatment changes. Thus, this endpoint was not analysed by NOAC type.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dabigatran | Reason for Treatment Changes | Lack of efficacy | 5 Participants |
| Dabigatran | Reason for Treatment Changes | Investigator decision | 30 Participants |
| Dabigatran | Reason for Treatment Changes | Patient decision | 7 Participants |
| Dabigatran | Reason for Treatment Changes | Adverse event | 14 Participants |