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To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | consented patients with NVAF in Taiwan with a previous VKA therapy, followed by switching to Pradaxa® |
| |
| Cohort B | patients being newly diagnosed with NVAF and initiated on Pradaxa® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pradaxa® | Drug | Dabigatran etexilate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). | Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®). |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison. | Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). |
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Inclusion criteria:
Cohort A (patients switched from VKA to Pradaxa)
OR Cohort B (patients newly initiated Pradaxa or VKA)
Exclusion criteria:
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Patients 20 years of age or older with a diagnosis of non-valvular atrial fibrillation (NVAF).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang-Hua Christian Hospital | Changhua | 500 | Taiwan | |||
| Show Chwan Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33784265 | Derived | Lee CW, Liu ME, Lee TM, Chang RY, Huang CY, Hu YF, Yeh HI. Patient satisfaction with dabigatrean and warfarin for stroke prevention in atrial fibrillation: Taiwan PASSION study. J Chin Med Assoc. 2021 Apr 1;84(4):375-382. doi: 10.1097/JCMA.0000000000000496. |
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Data was collected from approximately 20 medical centers or regional hospitals in Taiwan where Pradaxa® is taken as the prescription of stroke prophylaxis (or prevention) in Atrial Fibrillation (AF). Data was collected between June 23, 2017 and Jan 11, 2019. 10 enrolled participants were removed due to screening failures before entering the study.
This non-interventional study enrolled patients in Taiwan with a previous Vitamin K Antagonist (VKA) therapy, followed by switching to Pradaxa® (one of the novel oral anticoagulants (NOACs)) or patients being newly diagnosed with Non-Valvular Atrial Fibrillation (NVAF) and initiated on Pradaxa® or VKA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily. |
| FG001 | Cohort B - Pradaxa® |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2019 | Jan 8, 2020 |
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| Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®). |
| Description of PACT-Q1 Items for Patients in Cohort B at Baseline | The PACT-Q1 was composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/Completely/Very much). | Baseline |
| Changhua |
| Taiwan |
| Chia-Yi Christian Hospital | Chia-Yi City | 40705 | Taiwan |
| Hsinchu MacKay Memorial Hospital | Hsinchu | Taiwan |
| National Taiwan University Hospital-Hsin-Chu Branch | Hsinchu | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| E-Da Hospital | Kaohsiung City | 824 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan |
| Taipei Medical University-Shuang Ho Hospital | New Taipei City | 235 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| NCKUH | Tainan | 704 | Taiwan |
| Chi Mei Medical Center | Tainan | 710 | Taiwan |
| Tainan Municipal An-Nan Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Taipe Veterans General Hospital | Taipei | 11217 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Shin Kong International HealthCare Center | Taipei | Taiwan |
| Taipei Municipal Wanfang Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital(TaoYuan) | Taoyuan | 330 | Taiwan |
| National Taiwan University Hospital Yun-Lin Branch | Yunlin County | 632 | Taiwan |
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily. |
| FG002 | Cohort B - VKA | Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician. |
|
| Started (Eligible Participants as FAS) |
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| COMPLETED |
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| NOT COMPLETED |
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|
Full analysis set (FAS): This set included all subjects who were eligible for study participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily. |
| BG001 | Cohort B - Pradaxa® | Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily. |
| BG002 | Cohort B - VKA | Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). | FAS | Posted | Mean | Standard Deviation | Units on Scale | Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®). |
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| Primary | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison. | FAS | Posted | Mean | Standard Deviation | Units on Scale | Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA). |
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| Secondary | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). | FAS | Posted | Mean | Standard Deviation | Units on scale | Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®). |
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| Secondary | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | The PACT-Q1 was composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/Completely/Very much). | FAS | Posted | Mean | Standard Deviation | Units on scale | Baseline |
|
From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up.
Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA.
There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
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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 | Cohort A | Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily. | 0 | 148 | 1 | 148 | 0 | 148 |
| EG001 | Cohort B - Pradaxa® | Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily. | 11 | 978 | 4 | 978 | 0 | 978 |
| EG002 | Cohort B - VKA | Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician. | 0 | 48 | 0 | 48 | 0 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolic stroke | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 22.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 15, 2017 | Jan 8, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Convenience - Visit 3 |
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| Satisfaction - Baseline |
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| Satisfaction - Visit 2 |
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| Satisfaction - Visit 3 |
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| 0.0001 |
| Other |
| Within group comparison of Baseline satisfaction with that of Visit 2. | Paired t-test | 0.0031 | Other |
| Within group comparison of Baseline satisfaction with that of Visit 3. | Paired t-test | 0.0001 | Other |
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
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