An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 75 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by Boehringer Ingelheim · Observational
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.
Approximately 1.000 patients with NVAF currently on NOAC treatment and having initiated their first NOAC starting from November 2016 (Health Authorities positioning report publication) are planned to be included in the study. To minimize selection bias at the patient level, 10 consecutive patients from each site who meet entry criteria will be enrolled.
Exclusion Criteria:
-if the current participating patient participate in any clinical trial of a drug or device will be excluded
patients with Non Valvular Atrial Fibrillation
Drug: NOAC
New Oral Anticoagulant
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
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
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
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
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
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)
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)
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.
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)
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)
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
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)
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.
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)
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.
| Milestone | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
|---|---|---|---|---|
| Started | 314 | 253 | 266 | 130 |
| Completed | 314 | 253 | 266 | 130 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Years | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | All Patients |
|---|---|---|---|---|---|
| Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | 72.8 ± 9.9 | 72.5 ± 10.7 | 72.6 ± 9.8 | 74.0 ± 10.0 | 72.8 ± 10.1 |
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.
| Unit on Scale | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | All Patients |
|---|---|---|---|---|---|
| Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | 3.2 ± 1.5 | 3.3 ± 1.6 | 3.3 ± 1.5 | 3.3 ± 1.5 | 3.3 ± 1.5 |
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)
| Participants | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | All Patients |
|---|---|---|---|---|---|
| Low risk | 3 | 10 | 3 | 0 | 16 |
| Moderate risk | 53 | 34 | 36 | 21 | 144 |
| High risk | 252 | 207 | 215 | 108 | 782 |
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.
| unit on scale | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | All Patients |
|---|---|---|---|---|---|
| Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | 1.8 ± 1.0 | 1.8 ± 1.1 | 1.7 ± 1.1 | 1.8 ± 1.0 | 1.8 ± 1.1 |
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)
| Participants | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | All Patients |
|---|---|---|---|---|---|
| Low risk | 17 | 29 | 27 | 11 | 84 |
| Moderate risk | 219 | 157 | 170 | 86 | 632 |
| High risk | 72 | 65 | 56 | 31 | 224 |
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.
| Participants | All Patients |
|---|---|
| Reason 1 | 88 |
| Reason 2 | 10 |
| Reason 3 | 16 |
| Reason 4 | 16 |
| Reason 5 | 271 |
| Reason 6 | 102 |
| Reason 7 | 342 |
| Reason 8 | 118 |
Mean number of visits to the physician per year considered for the NOAC Management.
| visits per year | All Patients |
|---|---|
| Mean Number of Visits to the Physician Per Year | 2.0 ± 1.1 |
Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).
| Months | All Patients |
|---|---|
| First NOAC | 9.4 ± 6.5 |
| All NOAC | 9.6 ± 6.5 |
| Subsequent NOAC | 5.1 ± 4.1 |
Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC
| Participants | All Patients |
|---|---|
| Discontinue treatment | 4 |
| Dose adjustment | 20 |
| Change to a new NOAC | 32 |
| No change | 907 |
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.
| Participants | All Patients |
|---|---|
| Dabigatran 110 mg | 5 |
| Dabigatran 150 mg | 4 |
| Rivaroxaban 10 mg | 1 |
| Rivaroxaban 15 mg | 2 |
| Rivaroxaban 20 mg | 4 |
| Apixaban 2.5 mg | 2 |
| Apixaban 5 mg | 8 |
| Edoxaban 30 mg | 2 |
| Edoxaban 60 mg | 4 |
Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.
| Participants | All Patients |
|---|---|
| Lack of efficacy | 5 |
| Investigator decision | 30 |
| Patient decision | 7 |
| Adverse event | 14 |
Number of patient with Previous Treatment with Vitamin K Antagonists.
| Participants | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | All Patients |
|---|---|---|---|---|---|
| Yes | 146 | 125 | 100 | 53 | 424 |
| No | 168 | 128 | 166 | 77 | 539 |
Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC
| Months | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | All Patients |
|---|---|---|---|---|---|
| Duration of Previous VKA Treatment | 46.6 ± 52.5 | 37.0 ± 50.6 | 54.5 ± 58.9 | 34.0 ± 47.9 | 43.8 ± 53.2 |
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?
| Participants | All Patients |
|---|---|
| Question 1. — Yes | 845 |
| Question 1. — No | 118 |
| Question 2. — Yes | 820 |
| Question 2. — No | 143 |
| Question 3. — Yes | 766 |
| Question 3. — No | 197 |
| Question 4. — Yes | 333 |
| Question 4. — No | 630 |
Collected over From Informed consent signed until the end of the trial, up to 12 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran | 1/314 (0.3%) | 3/314 (1%) | 0/314 (0%) |
| Event | Dabigatran |
|---|---|
| Sudden deathGeneral disorders | 1/314 |
| Ischaemic strokeNervous system disorders | 1/314 |
| Cerebrovascular disorderNervous system disorders | 1/314 |
The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).
| Age, Continuous(Years) | All Patients |
|---|---|
| Mean | 73.6 ± 10.1 |
| Sex: Female, Male(Participants) | All Patients |
|---|---|
| Female | 406 |
| Male | 557 |
| Race and Ethnicity Not Collected(Participants) | All Patients |
|---|
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Boehringer Ingelheim