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The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch Patients / A | Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa. |
| |
| New Patients / B | Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pradaxa (dabigatran) | Drug | Pradaxa (dabigatran etexilate)110mg or 150mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment | Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis. | Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) |
| Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment | Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis. | Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA) |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score | CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. | Baseline (Visit1) |
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Inclusion criteria:
Cohort A:
OR
Cohort B:
Exclusion criteria:
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SEASK Patients with Non valvuar Atrial Fribrillation
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harapan Kita National Cardiovascular Center | Jakarta Barat | 11420 | Indonesia | |||
| Rumah Sakit Bina Waluya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34857666 | Derived | Lee YS, Oh YS, Choi EK, Chern AKC, Jiampo P, Chutinet A, Hanafy DA, Trivedi P, Zhai D. Patient perception and treatment convenience of dabigatran versus vitamin K antagonist when used for stroke prophylaxis in atrial fibrillation: Real-world Evaluation of Long-term Anticoagulant Treatment Experience (RE-LATE) study. Open Heart. 2021 Dec;8(2):e001745. doi: 10.1136/openhrt-2021-001745. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A (Switch Patients - Pradaxa) | Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa. |
| FG001 | Cohort B (New Patients - 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 | Jan 2, 2018 | Dec 11, 2018 |
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| Vitamin K antagonist |
| Drug |
Vitamin K antagonist or Pradaxa |
|
Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis. |
| Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups | Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. | Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) |
| Patient Characterization at Baseline - Categorical Parameters | Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP). | Baseline (Visit1) |
| Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A | Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A) | Baseline (Visit1) |
| Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score | HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. | Baseline (Visit1) |
| 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 (Visit1) |
| Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 score. | Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) |
| Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively. The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation. The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much). | Baseline (Visit1) |
| Jakarta Timur |
| 13750 |
| Indonesia |
| Rumah Sakit Siloam Lippo Karawaci, Tangerang | Tangerang | 15811 | Indonesia |
| Hospital Sultanah Bahiyah | Alor Star | 05460 | Malaysia |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| Hospital University Kebangsaan Malaysia | Kuala Lumpur | 56000 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | 25100 | Malaysia |
| UiTM Sg Buloh Campus | Sg Buloh | 47000 | Malaysia |
| National Heart Center | Singapore | 169609 | Singapore |
| Changi General Hospital | Singapore | 529889 | Singapore |
| Korea University Ansan Hospital | Ansan | 136-705 | South Korea |
| Sejong General Hospital | Bucheon-si | 422-711 | South Korea |
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Pusan National Univ. Hosp | Busan | 602-739 | South Korea |
| Soon Chun Hyang University Hospital Cheonan | Cheonan | 31151 | South Korea |
| Dankook University Hospital | Cheonan | 330-715 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 700-712 | South Korea |
| Kyungpook National Univ. Hosp | Daegu | 700-721 | South Korea |
| Yeungnam University Medical Center | Daegu | 705-703 | South Korea |
| Chungnam National University Hospital | Daejoen | 301721 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Chosun University Hospital | Gwangju | 61453 | South Korea |
| Wonkwang University School of Medicine & Hospital | Iksan | 570-711 | South Korea |
| Inha University Hospital | Incheon | 400 711 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Jeju National University Hospital | Jeju City | 690-767 | South Korea |
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
| Gyeongsang National University Hospital | Jinju | 660-702 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 463-707 | South Korea |
| The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | 06591 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| VHS Medical Center | Seoul | 134-791 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Gangnam Severance Hospital | Seoul | 135-720 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Chung-Ang University Hospital | Seoul | 156-755 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 158-710 | South Korea |
| Ajou University Hospital | Suwon | 443-380 | South Korea |
| Wonju Severance Christian Hosp | Wŏnju | 220-701 | South Korea |
| Bhumibol Adulyadej Hospital | Bangkok | 10220 | Thailand |
| King Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Pramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Chiangmai University | Chiang Mai | 50200 | Thailand |
| Thammasat University Hospital | Pathum Tani | 12120 | Thailand |
Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa |
| FG002 | Cohort B (New Patients - VKA) | Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A (Switch Patients - Pradaxa) | Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa. |
| BG001 | Cohort B (New Patients - Pradaxa) | Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa |
| BG002 | Cohort B (New Patients - VKA) | Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist 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 | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Mean | Standard Deviation | Years |
| |||||||||
| Age, Customized | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries | Count of Participants | Participants |
| ||||||||||
| Sex: Female, Male | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Count of Participants | Participants |
| ||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Non-South Korea includes four countries, and they are Indonesia, Malaysia, Singapore, and Thailand. | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries | Count of Participants | Participants |
| |||||||||
| Type of hospital or practice | Type of hospital or practice (Healthcare system characteristics) | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Count of Participants | Participants |
| |||||||||
| Owner of medical practice | Owner of medical practice (Healthcare system characteristics) | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Count of Participants | Participants |
| |||||||||
| Speciality of treating physician | Speciality of treating physician (Healthcare system characteristics) | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Count of Participants | Participants |
| |||||||||
| Baseline creatinine clearance category | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries | Count of Participants | Participants |
| ||||||||||
| CHA2DS2-VASc score | CHA2DS2-VASc score: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes mellitus, Stroke/Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Count of Participants | Participants |
| |||||||||
| HAS-BLED score | HAS-BLED score: Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. | The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Count of Participants | Participants |
|
| 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, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment | Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis. | The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Posted | Mean | Standard Deviation | Unit on scale | Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) |
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| Primary | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment | Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis. | The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Posted | Mean | Standard Deviation | Unit on scale | Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA) |
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| Primary | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups | Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis. | The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients. | Posted | Mean | Standard Deviation | Unit on scale | Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) |
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| Primary | Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups | Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. | The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients. | Posted | Mean | Standard Deviation | Unit on scale | Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) |
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| Primary | Patient Characterization at Baseline - Categorical Parameters | Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP). | Eligible patients who took the prescribed treatment and without an important protocol violation | Posted | Number | Percentage of participant | Baseline (Visit1) |
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| Secondary | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score | CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. | Eligible patients who took the prescribed treatment and without an important protocol violation | Posted | Mean | Standard Deviation | unit on scale | Baseline (Visit1) |
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| Secondary | Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score | HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. | Eligible patients who took the prescribed treatment and without an important protocol violation | Posted | Mean | Standard Deviation | unit on scale | Baseline (Visit1) |
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| 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 patients who took the prescribed treatment and without an important protocol violation | Posted | Mean | Standard Deviation | mL/min | Baseline (Visit1) |
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| Primary | Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A | Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A) | Eligible patients who took the prescribed treatment and without an important protocol violation | Posted | Mean | Standard Deviation | Years | Baseline (Visit1) |
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| Secondary | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 score. | The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. | Posted | Mean | Standard Deviation | Unit on scale | Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) |
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| Secondary | Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B | For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively. The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation. The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much). | The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. PACT-Q1 data which were collected after the first dose or using incorrect procedure were excluded from the summary. | Posted | Mean | Standard Deviation | Unit on scale | Baseline (Visit1) |
|
From the first administration of study medication until end of the study, up to 406 days
In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Not provided
| 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 (Switch Patients - Pradaxa) | Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa. | 1 | 379 | 5 | 379 | 0 | 379 |
| EG001 | Cohort B (New Patients - Pradaxa) | Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa | 0 | 591 | 1 | 591 | 0 | 591 |
| EG002 | Cohort B (New Patients - VKA) | Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician. | 0 | 343 | 6 | 343 | 0 | 343 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| International normalised ratio increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
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Not provided
The choice of anticoagulant treatment was at the discretion of the treating physician and independent from study participation. The planned between-country comparisons of study results could not be performed or were not meaningful when performed.
Not provided
Not provided
Not provided
| 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 | Jan 25, 2016 | Dec 11, 2018 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
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| Satisfaction dimension score: Baseline |
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| Satisfaction dimension score: Second assessment |
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Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes. |
| Paired t-test |
| 0.0174 |
p-value of paired t-test compared to baseline |
| Other |
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| Participants |
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Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician. |
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