| 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. | The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). | Posted | | Mean | Standard Deviation | Years | | Start of the first NOAC treatment | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC. | | OG001 | Rivaroxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC. | | OG002 | Apixaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC. | | OG003 | Edoxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC. | | OG004 | 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. |
| | Units | Counts |
|---|
| Participants | - OG000314
- OG001253
- OG002266
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00072.8± 9.9
- OG00172.5± 10.7
- OG00272.6± 9.8
- OG003
|
|
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | Unit on Scale | | Start of the first NOAC treatment | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC. | | OG001 | Rivaroxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC. | |
|
| 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:
- Low risk (score 0 in male; score 1 in female)
- Moderate risk (score 1 in male; score 2 in female)
- High risk (score ≥2 in male; score ≥3 in female)
| 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. | Posted | | Count of Participants | | Participants | | Start of the first NOAC treatment | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC. | | OG001 | Rivaroxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC. | | OG002 | Apixaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | unit on scale | | Start of the first NOAC treatment | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC. | | OG001 | Rivaroxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC. | | OG002 | Apixaban | |
|
| 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:
- Low risk (score 0)
- Moderate risk (score 1-2)
- High risk (score ≥3)
| 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. | Posted | | Count of Participants | | Participants | | Start of the first NOAC treatment | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC. | | OG001 | Rivaroxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC. | | OG002 | Apixaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC. | | OG003 |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | single visit (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Mean Number of Visits to the Physician Per Year | Mean number of visits to the physician per year considered for the NOAC Management. | 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. | Posted | | Mean | Standard Deviation | visits per year | | 1 year (data collected during single visit on day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Duration of First NOAC, All NOAC and Subsequent NOAC Treatment | Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC). | 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. | Posted | | Mean | Standard Deviation | Months | | 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. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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 | 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. | Posted | | Count of Participants | | Participants | | single visit (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | single visit (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | Start of the first NOAC treatment | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Number of Patients With Previous Treatment With Vitamin K Antagonists | Number of patient with Previous Treatment with Vitamin K Antagonists. | The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). | Posted | | Count of Participants | | Participants | | single visit (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC. | | OG001 | Rivaroxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC. | | OG002 | Apixaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC. | | OG003 | Edoxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC. |
|
| 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 | 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. | Posted | | Mean | Standard Deviation | Months | | Through the observational period with an average of 43.8 months, data collected during a single visit. | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC. | | OG001 | Rivaroxaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC. | | OG002 | Apixaban | Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC. | | OG003 |
|
| 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? | 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. | Posted | | Count of Participants | | Participants | | single visit (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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