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Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | Patients switched from vitamin K antagonist (VKA) to dabigatran |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment | The PACT-Q is self-administered quest. which was developed as means to investigate patients' satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). PACT-Q2 quest. is made up of two domains: (1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question & converting to a scale from 0 to 100. (2) Satisfaction with the anticoagulant treatment (7 items): This domain is calculated by adding scores for each of the 7 items in question & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 2 (second assessment) as mean & standard deviation (SD). | When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2) |
| Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment | The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 3 (last assessment) as mean and standard deviation (SD). | When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | CHA2DS2-VASc stroke risk score is calculated based on following conditions: Congestive heart failure/left ventricular dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus,Stroke/Transient Ischaemic Attack (TIA)/thromboembolism,Vascular disease (history of myocardial infarction, peripheral artery disease or aortic plaque) ,Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on following conditions: Uncontrolled hypertension with Systolic Blood pressure (SBP) ≥ 160 mmHg,Kidney failure,liver failure,History of stroke,History of bleeding, anaemia or predisposition to bleeding,Unstable/high or poor international normalized ratio (INR) (<60% of time within therapeutic range),Elderly (>65 years),Medications that affect haemostasis,Consumptions of ≥8 alcoholic drinks per week.CHA2DS2-VASc stroke risk score & HAS-BLED bleeding risk score range from 0 to 9 with 0 being outcome with low stroke risk for CHA2DS2-VASc and being with low bleeding risk for HAS-BLED. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
spanish patients with a diagnosis of non-valvular atrial fibrillation
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Spain |
All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met.
The data collection periods:
Questionnaire (quest.)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate (Pradaxa®) | Patients with Non-valvular atrial fibrillation (NVAF) who were treated with vitamin K antagonists (VKAs) and subsequently started daily oral dose of Pradaxa® 110 milligram (mg) or 150 mg hard capsules containing dabigatran etexilate according to the Summary of Product characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible patients: All patients (pts) fulfilling all inclusion criteria and no exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total | Patients with Non-valvular atrial fibrillation (NVAF) who were treated with vitamin K antagonists (VKAs) and subsequently started daily dose of Pradaxa® 110 mg or 150 mg hard capsules containing dabigatran etexilate according to the Summary of Product characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community. |
| 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 | Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment | The PACT-Q is self-administered quest. which was developed as means to investigate patients' satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). PACT-Q2 quest. is made up of two domains: (1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question & converting to a scale from 0 to 100. (2) Satisfaction with the anticoagulant treatment (7 items): This domain is calculated by adding scores for each of the 7 items in question & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 2 (second assessment) as mean & standard deviation (SD). | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. "as-treated" analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included | Posted | Mean | Standard Deviation | Units on Scale | When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2) |
From signing the informed consent till end of the study; up to 365 days
Not provided
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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 | Dabigatran Etexilate (Pradaxa®) | Patients with Non-valvular atrial fibrillation (NVAF) who were treated with vitamin K antagonists (VKAs) and subsequently started daily oral dose of Pradaxa® 110 milligram (mg) or 150 mg hard capsules containing dabigatran etexilate according to the Summary of Product characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA v20.0. | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2015 | Sep 30, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2018 | Sep 30, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment | The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with DVT, PE or AF. The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Visit 2( second assessment), Visit 3 (last assessment) as mean and standard deviation (SD). | 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
| Baseline |
| Patient Characteristics at Baseline - Categorical Parameters | Categorical parameters of the patient characteristics at baseline included age, Risk factors associated with stroke and/or haemorrhage in the medical history (MH), co-morbidities (CoMo), concomitant medication (CM) and dosing of Pradaxa® (DoP). Haemorrhagic risk (HAS-BLED) is categorized as Low risk (score 0), Moderate risk (score 1-2) and High Risk (score ≥3). Thromboembolic risk (CHA2DS2-VASc) is categorized as Low risk (score 0 in male and 1 in female), Moderate risk (score 1 in male and 2 in female) and High Risk (score ≥2 in male and ≥3 in female). Stages of kidney disease are categorized based on Cockcroft-Gault review as below: No kidney failure (> 80 ml/min), Mild kidney failure (50-80 ml/min), Moderate kidney failure (30-49 ml/min), Severe kidney failure (15-29 ml/min) and End-stage kidney failure/dialysis (< 15 ml/min). | Baseline |
| Patient Characteristics at Baseline - Creatinine Clearance | Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics. | Baseline |
| Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration | Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics. | Baseline |
| Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa® | Categories of reasons for switching from VKAs to Pradaxa® are as below:
A single patient may have specified more than one reason | Baseline |
| Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid | Reasons for for changing the dose of Pradaxa®: 150 mg/bid to 110 mg/bid are categorized as below: 1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason | 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
| Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid | Reasons for for changing the dose of Pradaxa®: 110 mg/bid to 150 mg/bid are categorized as below: 1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason | 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
| Reasons for no Longer Receiving Pradaxa® Treatment | Reasons for no longer receiving Pradaxa® treatment categorized as below:
| 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race information is provided. Ethnicity information was not collected for this study. | Count of Participants | Participants |
|
|
|
|
|
| Primary | Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment | The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 3 (last assessment) as mean and standard deviation (SD). | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. "as-treated" analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included | Posted | Mean | Standard Deviation | Units on Scale | When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
|
|
|
|
| Primary | Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment | The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with DVT, PE or AF. The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Visit 2( second assessment), Visit 3 (last assessment) as mean and standard deviation (SD). | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. "as-treated" analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included | Posted | Mean | Standard Deviation | unit on scale | 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
|
|
|
|
| Secondary | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | CHA2DS2-VASc stroke risk score is calculated based on following conditions: Congestive heart failure/left ventricular dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus,Stroke/Transient Ischaemic Attack (TIA)/thromboembolism,Vascular disease (history of myocardial infarction, peripheral artery disease or aortic plaque) ,Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on following conditions: Uncontrolled hypertension with Systolic Blood pressure (SBP) ≥ 160 mmHg,Kidney failure,liver failure,History of stroke,History of bleeding, anaemia or predisposition to bleeding,Unstable/high or poor international normalized ratio (INR) (<60% of time within therapeutic range),Elderly (>65 years),Medications that affect haemostasis,Consumptions of ≥8 alcoholic drinks per week.CHA2DS2-VASc stroke risk score & HAS-BLED bleeding risk score range from 0 to 9 with 0 being outcome with low stroke risk for CHA2DS2-VASc and being with low bleeding risk for HAS-BLED. | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | unit on scale | Baseline |
|
|
|
| Secondary | Patient Characteristics at Baseline - Categorical Parameters | Categorical parameters of the patient characteristics at baseline included age, Risk factors associated with stroke and/or haemorrhage in the medical history (MH), co-morbidities (CoMo), concomitant medication (CM) and dosing of Pradaxa® (DoP). Haemorrhagic risk (HAS-BLED) is categorized as Low risk (score 0), Moderate risk (score 1-2) and High Risk (score ≥3). Thromboembolic risk (CHA2DS2-VASc) is categorized as Low risk (score 0 in male and 1 in female), Moderate risk (score 1 in male and 2 in female) and High Risk (score ≥2 in male and ≥3 in female). Stages of kidney disease are categorized based on Cockcroft-Gault review as below: No kidney failure (> 80 ml/min), Mild kidney failure (50-80 ml/min), Moderate kidney failure (30-49 ml/min), Severe kidney failure (15-29 ml/min) and End-stage kidney failure/dialysis (< 15 ml/min). | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Patient Characteristics at Baseline - Creatinine Clearance | Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics. | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | millilitre/ minute [mL/min] | Baseline |
|
|
|
| Secondary | Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration | Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics. | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Months | Baseline |
|
|
|
| Secondary | Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa® | Categories of reasons for switching from VKAs to Pradaxa® are as below:
A single patient may have specified more than one reason | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid | Reasons for for changing the dose of Pradaxa®: 150 mg/bid to 110 mg/bid are categorized as below: 1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Count of Participants | Participants | 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
|
|
|
| Secondary | Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid | Reasons for for changing the dose of Pradaxa®: 110 mg/bid to 150 mg/bid are categorized as below: 1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason | Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Count of Participants | Participants | 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
|
|
|
| Secondary | Reasons for no Longer Receiving Pradaxa® Treatment | Reasons for no longer receiving Pradaxa® treatment categorized as below:
| Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. | Posted | Count of Participants | Participants | 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3) |
|
|
|
| 8 |
| 653 |
| 14 |
| 653 |
| 0 |
| 653 |
| Cardiac failure | Cardiac disorders | MedDRA v20.0. | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v20.0. | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v20.0. | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v20.0. | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v20.0. | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v20.0. | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA v20.0. | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA v20.0. | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v20.0. | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.0. | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.0. | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.0. | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA v20.0. | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA v20.0. | Systematic Assessment |
|
| Waldenstrom's macroglobulinaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.0. | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Satisfaction-Baseline |
|
|
| Satisfaction-Visit 3 |
|
|
| Other |
Within group comparison of Baseline satisfaction with that of Visit 3. |
|
| Satisfaction-Visit 2 |
|
|
| Satisfaction-Visit 3 |
|
|
| <0.0001 |
| Other |
|
| MH: Ischaemic stroke |
|
|
| MH: Thromboembolisms |
|
|
| MH: Diabetes mellitus |
|
|
| MH: Arterial hypertension |
|
|
| MH: Ischemic heart disease or Heart failure |
|
|
| MH: Peripheral arterial disease |
|
|
| MH: Kidney failure |
|
|
| MH: Liver failure |
|
|
| CoMo: Yes |
|
|
| CoMo: No |
|
|
| CoMo: Not assessed |
|
|
| CM: Yes |
|
|
| CM: No |
|
|
| DoP: 110 mg twice daily |
|
|
| DoP: 150 mg twice daily |
|
|
| HAS-BLED: Low |
|
|
| HAS-BLED: Moderate |
|
|
| HAS-BLED: High |
|
|
| CHA2DS2-VASc: Low |
|
|
| CHA2DS2-VASc: Moderate |
|
|
| CHA2DS2-VASc: High |
|
|
| No kidney failure |
|
|
| Mild kidney failure |
|
|
| Moderate kidney failure |
|
|
| Severe kidney failure |
|
|
| End-stage kidney failure/dialysis |
|
|
| Title | Measurements |
|---|---|
|
| Arterial thromboembolic episodes |
|
| INR not in range |
|
| INR management |
|
| Pts decision |
|
| Other |
|
|
| >80 years- Visit 2 |
|
|
| Other reason- Visit 2 |
|
|
| High risk of bleeding- Visit 3 |
|
|
| Moderate renal failure- Visit 3 |
|
|
| >80 years- Visit 3 |
|
|
| Other reason- Visit 3 |
|
|
|
| >80 years- Visit 2 |
|
|
| Other reason- Visit 2 |
|
|
| High risk of bleeding- Visit 3 |
|
|
| Moderate renal failure- Visit 3 |
|
|
| >80 years- Visit 3 |
|
|
| Other reason- Visit 3 |
|
|
|
| Exitus- Visit 2 |
|
|
| Other reason- Visit 2 |
|
|
| Treatment change- Visit 3 |
|
|
| Adverse event-- Visit 3 |
|
|
| Exitus- Visit 3 |
|
|
| Other reason- Visit 3 |
|
|